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U.S. Department of Health and Human Services

MedSun: Newsletter #56, January 2011

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Newsletter #56, January 2011

Articles

Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath

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FDA MedWatch Safety Alert

The Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System are recalled because the catheters can become stuck in the sheath. When the IAB catheter becomes stuck, the user is unable to move the IAB catheter forward or backward, causing delay in therapy, bleeding or arterial injury. Customers are advised to immediately discontinue use of any affected products.

Additional Information:

FDA MedWatch Safety Alert. Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath. December 29, 2010.
http://wcms.fda.gov/FDAgov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238408.htm

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ev3 NanoCross .014inch OTW PTA Dilatation Catheter: Class I Recall - Potential for cracking or breaking

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FDA MedWatch Safety Alert

There is potential for cracking or breaking during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in separation of catheter components and potential embolization catheter fragments. Ev3 notified healthcare facilities of the issue with the NanoCross .014” OTW PTA Dilatation Catheter and requested that all affected products are located and removed from use.

Additional Information:

FDA MedWatch Safety Alert. ev3 NanoCross .014" OTW PTA Dilatation Catheter: Class I Recall - Potential for cracking or breaking. December 28, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238291.htm

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Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results

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FDA MedWatch Safety Alert

FDA and Abbott Diabetes Care notified healthcare professionals and patients of a recall of 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The problem relates to a defect that inhibits sufficient absorption of blood into the test strip. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result. Test strips with lot numbers that have been recalled may give falsely low blood glucose results. Both scenarios pose risks to health. Patients with diabetes should be aware of this problem and take steps to prevent it from affecting their health. Customers can check if they have tests trips from the recalled lots by visiting Abbott’s website to look up their product lot number: http://www.precisionoptiuminfo.com.

Additional Information:

FDA MedWatch Safety Alert. Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results. December 22, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237910.htm

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Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall

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FDA MedWatch Safety Alert

Use of the recalled product has led to removal of greater amounts of red blood cells than intended, resulting in hemodilution. 255 units are subject to this recall, including Red Blood Cell (RBC) Set (catalog number 9007601), lot numbers WKT252, YLT061, ZCT011, and ZGT052, manufactured from October 1, 2007 to July 30, 2010. Customers are instructed to discontinue using, dispensing and distributing the affected product and return product to Fresenius Kabi.

Additional Information:

FDA MedWatch Safety Alert. Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall. December 21, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237707.htm

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B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag

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FDA MedWatch Safety Alert

When the addEASE binary connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a small amount of visible particles in the solution. The particles can potentially enter a patient's body and lead to serious adverse health consequences, such as pulmonary embolism, stroke, or heart attack. B Braun sent an Urgent Medical Device Recall letter to its customers informing them of the recall and advising them to immediately stop using or distributing addEASE connectors.

Additional Information:

FDA MedWatch Safety Alert. B. Braun addEASE Binary Connector: Class I Recall - Stopper Fragments May Enter Bag. November 30, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm235283.htm

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Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error

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FDA MedWatch Safety Alert

FDA and Penumbra notified healthcare professionals of a Class I recall due to a manufacturing error. Mid-shaft joint failures were occurring in some Reperfusion Catheters 032 produced from lot F15020. The company is advising customers to discontinue use of the product.

Additional Information:

FDA MedWatch Safety Alert. Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error. December 8, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm236155.htm

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Temporal Trends in Rates of Patient Harm Resulting from Medical Care

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The New England Journal of Medicine

Findings from a study of 10 North Carolina hospitals suggest that patient harms remain common, with little evidence of widespread improvement. Further efforts are needed to translate effective safety interventions into routine practice and to monitor health care safety over time.

Additional Information:

The New England Journal of Medicine. Temporal Trends in Rates of Patient Harm Resulting from Medical Care. CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. November 25, 2010. 363:2124-2134.
http://www.nejm.org/doi/full/10.1056/NEJMsa1004404

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LabNet

11 Gas Chromatography Safety Tips

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Lab Manager Magazine

Gas chromatography requires handling compressed gases (nitrogen, hydrogen, argon, helium), and flammable and toxic chemicals. Consult product MSDSs before using such hazardous products. The article include specific precautions for working with gas chromatographs.

Additional Information:

Lab Manager Magazine. 11 Gas Chromatography Safety Tips. November 2010.
http://www.labmanager.com/stips.asp?ID=153

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HeartNet

Stent fracture in the coronary and peripheral arteries

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PubMed Abstract

Inherent risks of stenting include restenosis and thrombosis. Recently, stent fractures have been recognized as a complication that may result in thrombosis, perforation, restenosis, and migration of the stent resulting in morbidity and mortality. The presentation of a patient with a fracture is highly variable, ranging from asymptomatic in nature, detected on routine screening without any sequelae, to sudden cardiac death related to a thrombosed coronary artery. As the knowledge of the variables that make stents prone to fracture are identified, better technologies and techniques can be employed to minimize the risk of this complication. This article reviews the available literature on stent fractures and complications using data found on PubMed, MEDLINE, the Manufacturer and User Facility Device Experience (MAUDE) database, and the Cochrane databases.

Additional Information:

PubMed. Stent Fracture in the Coronary and Peripheral Arteries. August 2010.
http://www.ncbi.nlm.nih.gov/pubmed/20806458

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Medtronic Sprint Quattro Secure S, model 6935 - Class 2 recall

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FDA Medical Device Recalls

Over-retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead. MedSun has received reports with this device. To read the event, please see the link provided in Additional Information below.

Additional Information:

FDA Medical Device Recalls. Medtronic Sprint Quattro Secure S, model 6935 – Class 2 recall. November 26, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95370

Related MedSun report. Sprint Quattro Secure Sprint Fidelis. May 9, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%5DS%3F%27%3F%3C%20%0A

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Medtronic Sprint Quattro Secure S, model 6947 - Class 2 Recall

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FDA Medical Device Recalls

Over-retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. This does not impact acute or chronic performance of successfully implanted leads. Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead. MedSun has received reports with this device. To read the events, please see the links provided in Additional Information below.

Additional Information:

FDA Medical Device Recalls. Medtronic Sprint Quattro Secure S, model 6947 – Class 2 recall. November 26, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95371

Related MedSun report. Sprint Quattro Secure CapSureFix Novus. July 28, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%5DS6%25O%3C%20%0A

Related MedSun report. Sprint Quattro Secure. December 19, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D3%3A%25O8%20%0A

Related MedSun report. Sprint Quattro Secure. June 12, 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2DK8%26OT%20%0A

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Medtronic Dual-Chamber External Temporary Pulse Generators Model 5388 - Class 2 recall

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FDA Medical Device Recalls

A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down at a later time while in use. Medtronic issued an Important Medical Device Correction letters, dated October 2010 and November 2010 to hospital's biomedical engineering department. Medtronic will contact the hospitals to return affected product for servicing. MedSun has received reports with this device. To read the events, please see the links provided in Additional Information below.

Additional Information:

FDA Medical Device Recalls. Medtronic Dual-Chamber External Temporary Pulse Generators Model 5388 – Class 2 recall. November 22, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95390

Related MedSun report. Medtronic Dual Chamber Temporary Pacemaker. February 10, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D7%3E%27%5FP%20%0A

Related MedSun report. Medtronic Temporary Pacemaker. March 25, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D7%3A%26%5F8%20%0A

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HomeNet

Considerations for the Design of Safe and Effective Consumer Health IT Applications in the Home

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PubMed Abstract

Consumer health IT applications have the potential to improve quality, safety and efficiency of consumers' interactions with the healthcare system. Yet little attention has been paid to human factors and ergonomics in the design of consumer health IT, potentially limiting the ability of health IT to achieve these goals. This paper presents the results of an analysis of human factors and ergonomics issues encountered by five projects during the design and implementation of home-based consumer health IT applications. Consumer health IT application design would benefit from the use of human factors and ergonomics design and evaluation methods.

Additional Information:

PubMed. Considerations for the Design of Safe and Effective Consumer Health IT Applications in the Home. October 2010.
http://www.ncbi.nlm.nih.gov/pubmed/20959321

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KidNet

Safety of Key Inhaled and Intravenous Drugs in Pediatrics: (SAFEKIDS) Initiative

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FDA Website

Recent non-clinical studies in juvenile animal models show that exposure to some anesthetics and sedatives is associated with memory and learning deficits. SAFEKIDS is a multi-year effort to address major gaps in scientific information concerning the safety of anesthetics and sedatives in pediatric age groups. FDA has also partnered with multiple stakeholders, such as professional anesthesiology societies, academic research institutions, patient advocacy groups, industry and other government and nonprofit organizations, to launch the SAFEKIDS Initiative.

Additional Information:

FDA. Safety of Key Inhaled and Intravenous Drugs in Pediatrics: (SAFEKIDS) Initiative. December 20, 2010.
http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231126.htm

FDA Press Release. FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners Public-Private Partnership - Will Assess Safety of Anesthetics and Sedatives in Young Children. March 13, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149543.htm

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period October 1 through October 31 2010. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

ANESTHESIOLOGY

Device:
Type: Condenser, Heat And Moisture (Artificial Nose)
Manufacturer: Ventlab Corp
Brand: Heat Moisture Exchanger (HME)
Model#: FH603005
Cat #: FH603005

Problem:
Several months ago, our facility was notified from this manufacturer that our usual HME Filter (part #FH603005) was on backorder. We agreed to use a substitute product (part #FH603008) while waiting for our normal product to arrive. While using this alternate product we identified many issues such as breakage, cracking, lot # concerns, and obvious glue additions. Recently we received shipments of the product we normally/previously used (#FH603005) which was no longer on backorder and began to utilize the filters on every adult anesthesia case in our OR. Our Anesthesia staff immediately began noticing issues/concerns with this product, all of which had not been an issue prior to the backorder. As previously reported with the substitute product (#FH603008), even though there is a printed spot suggesting "LOT" on each individually wrapped filter...there is nothing printed on the package which would indicate a lot number. The ONLY place a lot number is found is on the cardboard box these items are shipped within. This box is discarded as it is not allowed in our OR storage area...and because there is no lot number printed on the individual items we have lost the ability to track issues with particular lots. The purpose of this filter is to act as the patients "nose" while they are under anesthesia. These filters have a foam component which should arrive to us damp and remain "moist" upon opening and while on the machine within the breathing circuit system for the patient. Many of these filters are completely dry immediately upon opening. We were able to find one lone filter hiding in the back of a storage cabinet which appears to be from our original product (estimate 1.5 yrs old) and you can still visually see the moisture contained within the packaging. You aren't able to see moisture in any of the new items we recently received and the foam appears "dry". The materials buyer for our OR opened a newly shipped/previously unopened case of filters yesterday and we made an interesting discovery. Approximately 2/3 of the box appeared perfect...ready to be placed on the machine...sonic sealed as they should be. The remaining 1/3 of the filters had obviously been glued at the sonic weld site. You can see bubbles in the glue, smears, etc. (Keep in mind...the lot number is on the outside of the case so ALL product contained inside should be manufactured the same, on the same date, etc.) Clearly...this is not the case, some are hand glued, and others are sonic welded appropriately. One of the concerns previously reported with the substitute product (#FH603008) was it falling apart at the plastic sonic weld site. When we started seeing these same glue issues with the original product (no longer backordered) our facility began notifying the manufacturer’s representative that we were finding product with obvious glue additions. In a recent email to our facility, the representative assures us "this product does not use glue in assembly, they use a plastic weld process to attach the two sides". The representative was at our facility yesterday and witnessed the unopened case issues mentioned above and also confirmed glue was being used on these devices. Our biggest concern is has the manufacturer received clearance from the FDA to utilize glue on various components of these filters? If so, what type of glue is being used and what are the potential hazards to patients inhaling glue while under anesthesia, especially knowing these products are exposed to heat, moisture and VOLATILE ANESTHETIC AGENTS, etc. Or...has this manufacturer only been approved for using a sonic welder? All of these concerns were shared with the manufacturer’s representative while he was at our facility. The buyer for our OR has determined we will not be using HME filters from this vendor any longer. We have placed an order for an HME filter from GE which we have previously used and had no issues with. This new product will arrive in approximately a week and in the meantime we have no option but to use the filters being reported. We have notified all OR staff to be extra diligent and not to utilize ANY device with glue issues and will continue to troubleshoot these issues as they arise. To this date we are not aware of any patient injury/impact. Although the glue issues are of high concern to us knowing how long patients are under anesthesia and how long they could potentially be absorbing fumes, etc...from this unknown glue product, any chemical reaction(s), or how long post-procedure could this be a potential issue to patients.
We have 28 examples of product for evaluation purposes as well as photographs of concerns.
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Health Professional's Impression
======================
It is unknown whether the obvious glued welds could compromise the safety of the patient while under anesthesia.
======================
Manufacturer response for Heat Moisture Exchanger (HME) Filter, (brand not provided)
======================
The distributor (Tri-Anim) has been aware of these concerns since August when we first reported the same concerns with a replacement device we utilized while this (our usual) item was backordered. We are now seeing the same problems with our original product.


CARDIOVASCULAR

Device:
Type: Compressor, External, Cardiac, Powered
Manufacturer: Zoll
Brand: Autopulse Non-invasive Cardiac Support Pump
Model#: 100 platform

Problem:
A middle-aged patient was coding in the cardiac cath lab. Attempted to use the Zoll Autopulse. Device did not work. All batteries were drained of power. All batteries were used and each only provided approximately five compressions and then failed. According to the Zoll representative, we have been changing out the batteries every day and draining/charging as instructed. Patient required manual compressions for over an hour.
======================
Health Professional's Impression
======================
Current battery conditioner/charger is not putting the proper load test on the batteries to stimulate real life usage.


GENERAL & PLASTIC SURGERY

Device:
Type: Energy Platform
Manufacturer: Covidien Valleylab
Brand: Forcetriad

Problem:
Force triad had ground pad applied and handpiece plugged into monopolar 1 slot. Set at 35ct/35cg. When surgeon tried to use ESU, it would not work. Handpiece marked and removed from service.
======================
Manufacturer response for ESU, General Purpose, Forcetriad
======================
With assistance from Valleylab/Covidien technical support we were able to recreate the reported problem, which causes the power output to drop to near zero, preventing the user from using the device.

The device (generator) involved had been recently upgraded to software version 3.2, at the manufacturer's recommendations to prevent the problem from reoccurring. However we are still experiencing similar problems related to the software design of this system.


Device:
Type: Instrument, Ultrasonic Surgical, Curved Shears
Manufacturer: Ascent Healthcare Solutions
Brand: Ethicon Harmonic Focus
Model#: FCS9
Lot #: 1189100
Cat #: FCS9
Other #: Ultrasonic Curved Shears with Torque Wrench/Grip Assist 9cm long/16mm blade length

Problem:
OR staff report a reprocessed Ethicon harmonic scalpel failed when attempting to use for a thyroidectomy. When tested before use, it took 3 attempts to get it to actually pass test, then failed when went to initiate use. This device did not reach the patient, no injury, just delay due to troubleshooting issues. Reprocessed device replaced with a new Ethicon device of same type and procedure was completed with no further issues.


Device:
Type: Instrument, Ultrasonic Surgical, Curved Shears
Manufacturer: Ascent Healthcare Solutions
Brand: Ethicon Harmonic Ace
Model#: ACE36E
Lot #: 1231571
Cat #: ACE 36E

Problem:
OR Staff report, prior to procedure, this reprocessed Ethicon Harmonic ACE Shears passed the test for use. However when first attempting to use it for Laparoscopic Myotomy it would not fire appropriately, so was removed from service before coming into contact with the patient. No injury to the patient. The device was removed from field and was replaced with a new Ethicon Harmonic ACE Shear.


Device 1:
Type: Stapler, Reload, Surgical
Manufacturer: Covidien
Brand: Roticulator
Lot #: N0H0201
Cat #: 030451

Device 2:
Type: Stapler, Surgical
Manufacturer: Covidien
Brand: Endo Gia Universal
Lot #: N0F0340
Cat #: 030449

Problem:
At approximately 1425 hours, while attempting to staple across an artery with the Endo GIA device (stapler), the staple load appeared to misfire. After releasing the stapler, the artery bled as if it had just been cut, not stapled. When looking at the specimen and staple load at a later time, it looked like only one side of the staple load fired. The estimated blood loss (EBL) after firing the stapler went from 200cc to 1000cc. After not being able to get control of the bleeding with suction and anesthesia not being able to find a pressure with the arterial line or carotid pulse, doctors decided to emergently open the patient. Once open, they were able to visualize the bleeding, get it under control and see that there was only one row of staples where they resected the specimen. I have never seen this particular misfire. It seemed to fire fine but when it cut there was immediate hemorrhage and what we found when we opened was the distal (right) side had two rows of staples and a clean cut edge and looked like it should, and the left side had no staples and was cut. Of course this was the proximal side of the artery so she almost exsanguinated.

Device:
Type: System, Surgical, Computer Controlled Instrument
Manufacturer: Intuitive Surgical
Brand: Cannula Obturator
Model#: 420008
Other #: 8 mm

Problem:
The staff reported that the obturator broke when placed in the trocar on two different patients, with two different surgeons, in two different rooms for two different surgeries on the same day. It broke near the same spot in both cases. The staff were able to retrieve the item. They reported this as a recognized defect for this item. They did not feel that the break was related to surgical technique. Similar breakage has occurred in 5 other obturators.
======================
Health Professional's Impression
======================
There appears to be a common area of stress and/or weakness in the obturator. Staff feels that the plastic is not holding up to repeated steam sterilizations. Reprocessing has been completed according to manufacturer's recommendations. We are planning a simulation to see if we can re-produce the defect to evaluate product and technique.
======================
Manufacturer response per site reporter
======================
The representative thought it might be related to the way we process the equipment. He was not onsite, nor had he seen the actual defect. Manufacturer is coming to our facility to evaluate breakage.

See device images:
Image shows 4 broken obturators where device breakage can be seen at the top

Image is a close up of the 4th broken obturator plastic top

Image is a close up of the 5th broken obturator



GENERAL HOSPITAL

Device:
Type: Catheter, Implanted, Port
Manufacturer: Angiodynamics
Brand: Ct Smart Port
Model#: CT96STSD
Lot #: 995828

Problem:
Patient had port a catheter placed at this facility and returned six months later due to nonfunctioning catheter. Upon removal, it was noted the port tubing had broken completely apart and the detached portion had migrated to the patient's heart.
The remaining portion of the tubing was removed successfully in tact. There was no patient injury.


Device:
Type: Catheter, Short Term, Iv
Manufacturer: BD
Brand: Insyte Autoguard
Model#: 381433
Lot #: 9239851

Problem:
Several nurses tried to use the #20 gauge Insyte catheters and noted that the catheters were dull and not able to achieve venipuncture. The devices were pulled from inventory due to splitting of the catheters and burrs when withdrawn from the patients. The nurses did not recall specifically which patients were subject to the dull catheter needles; however no harm occurred to patients besides the need for multiple IV attempts. The staff switched to another box of 20g Insytes and did not have the reported problem. The box of Insyte catheters was sent back to the manufacturer.


Device:
Type: Catheter, Umbilical Artery
Manufacturer: Utah Medical
Model#: 4173505
Lot #: 1100477/ 1101120/ 1101553
Lollipop Icon

Problem:
A 3.5 umbilical line placed and fluid drop noted at the 15 cm mark. Line backing up and had to be replaced. No suture near area of leak. Lot numbers of umbilical lines on unit included in report. Physician stated line looked like it was fraying. UAC replaced without incident. The product was shipped back to the rep. There was no harm to the patient.


Device:
Type: Flu Vaccine Syringe
Manufacturer: Sanofi Pasteur Inc.
Brand: Fluzone
Lot #: ut3642aa
Other #: 5886

Problem:
The RN was giving a patient the flu vaccine in the physician's office. She attached the needle, held the syringe/needle upright, and expressed out all of the air. After preparing the patient's arm (specifically, the deltoid muscle), she inserted the needle and attempted to aspirate. Seeing no aspirate, she proceeded to depress the plunger to give the vaccine. At this point, the glass flange nearest to the plunger shattered. The nurse reports she met no resistance and there were no indications prior to the event that the device was faulty (e.g.: no cracks in the glass). The patient did not move, squirm, or tense the muscle during the injection. The patient was not harmed; however, the nurse's finger was cut in the process. There was no glass in the nurse's finger--only a small cut which was cleaned and a band-aid was applied. No further medical intervention was required for the nurse. Staff obtained another vaccine and administered it to the patient without difficulty. There was no delay or interruption in the patient's care. Of note, the vaccine is stored in a monitored refrigerator. The temperature in the refrigerator remains constant and the vaccine has not been subject to heat or freezing temperatures. The staff giving the vaccine is medically trained to perform this procedure and have done so many times--they are very experienced in giving injections. Staff does not know why this occurred.
======================
Health Professional's Impression
======================
Staff do not know.
======================
Manufacturer response for Flu vaccine syringe, Fluzone
======================
The physician's office manager contacted the manufacturer. An additional call was placed to the manufacturer, who confirmed that the product should be discarded.

See device images:
Image shows where the breakage can be seen on the flu vaccination syringe.  The glass flange nearest to the plunger shattered

Image shows Fluzone flu vaccination syringe.


Device:
Type: Port, Implanted, Catheter
Manufacturer: AngioDynamics
Brand: Vortex Vx Vascular Access Port
Lot #: 25384
Lollipop Icon

Problem:
The low profile AngioDynamics catheter stopped working. The surgeon decided to remove the catheter and discovered that it was broken during the explantation process.

See device image:
Broken AngioDynamics Catheter shows the location where the catheter broke causing it to stop working during explantation


Device:
Type: Pump, Infusion, Enteral
Manufacturer: ABBOTT LABORATORIES
Brand: Quantum
Model#: Quantum

Problem:
The attending nurse attempted to place the pump on "Hold" and the infusion was not interrupted.
======================
Health Professional's Impression
======================
There is the possibility of the pump continuing with an infusion causing patient to have fluid overload.


Device:
Type: Software, Emar/bmv
Manufacturer: MEDITECH
Brand: Meditech Magic 5. 62
Model#: Meditech Magic 5.62

Problem:
Nurse scans a medication that is not on patient profile. Scanner beeps with the same audible tone as a correct med, but a message pops up on the Meditech BMV (Bedside Medication Verification) screen on the PC with an "OK" button that is highlighted. The nurse continues to scan the next med without interacting with the screen and the error message is cleared.

What should happen is that a different audible tone would sound that would alert the nurse and the error would not clear unless the nurse interacted with the screen, selecting "OK" then "Exit" (F11) - the error message would not clear just by the nurse scanning another med.

Meditech tested scanning and received appropriate error messages for medication not on patient profile. Also reported that there isn't a two-way interface between Meditech and the scanner. Information is sent from the scanner to Meditech and there isn't a means for Meditech to send a response back to the scanner to generate a different tone based on the scanning activity.


Device 1:
Type: Warmer, Infant Radiant
Manufacturer: GE Healthcare
Model#: 4400
Cat #: 07062
Other #: BEC07060

Device 2:
Type: Warmer, Infant Radiant
Manufacturer: GE Healthcare
Model#: 4400
Other #: BEC 07062
Lollipop Icon

Problem:
Nurse encountered difficulty with the tilt function on the radiant warmer bed and was unable to adjust tilt.
When Biomedical engineer examined warmer, a roll of tape was found blocking the movement of the tilt bed. On further examination, the engineer found an "aneurysm" in the hydraulic cylinder hose that controls the tilt. If the hose had failed the bed would become unstable.


ORTHOPEDIC

Device:
Type: Arthroscope, Shaver Blade
Manufacturer: Ascent Healthcare Solutions
Brand: Dyonics Notchblaster
Model#: 7205329
Lot #: 1045689
Cat #: 7205329

Problem:
Patients were scheduled for right ACL reconstruction surgery. During both procedures, while the orthopedic surgeon was using Dyonics reprocessed Notchblasters, he noted the burrs to be dull while in use. The devices did work, but the surgeon felt the devices were not as effective as compared to new or unused arthroscopic burrs. Of note, these were two separate procedures for two separate patients. Both devices are from the same lot number and both have been retained for evaluation purposes. There was no injury to the patients; however extra surgical time was necessary to ensure each notchblaster completed the task they were used for.
======================
Health Professional's Impression
======================
They appeared to be dull
======================
Manufacturer response for Dyonics Notchblaster (Peach) 5.5mm, Dyonics Notchblaster
======================
Continuing to work through issues with manufacturer representative.


PHYSICAL MEDICINE

Device:
Type: Heel Warmer, Infant
Manufacturer: DeRoyal
Lot #: 23824150
Cat #: HNICU-100
Other #: 44-00184
Lollipop Icon

Problem:
When the nurse tried to activate the heel warmer by squeezing the contents, the device burst at the seam on the side. The solution got on the nurse's arms and the floor. The nurse reported a burning sensation from the solution. She initially tried to rinse off the solution, but the burning sensation did not subside. She then washed the areas with soap and water, but continued to experience the sensation. She sustained raised reddened areas on her arms where she came in contact with the warmer solution. The nursing staff feels excessive force has to be used to activate these warmers. The nurse manager feels that this excessive force required to activate the warmer contributed to the event. It was also reported that the floor was damaged from the solution.


RADIOLOGY

Device:
Type: Radiation Shield, Ceiling Mounted
Manufacturer: Ti-Ba Enterprises, Inc.
Brand: Mavig
Model#: Main assembly TS15U11
Other #: Shield Arm- OT25U50 Serial # 0804/11408 10Kg.

Problem:
An elderly patient was undergoing cardiac catheterization and coronary angiography. During the course of the procedure the Mavig X-ray shield suspension arm broke causing the lead shield to fall on the patient while lying on the cardiac cath lab table. The shield fell on the patient's face, resulting in a right forehead/orbital laceration which ultimately required sutures. Skull fracture and intracranial bleeding were ruled out. Long-term injury unlikely. The device/product failure was the direct cause of the patient's injuries.




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Lollipop IconSpecial Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Anesthesia or Analgesia Gas Machines

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"A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (Code of Federal Regulations, 2010)."

Over the past 2 years, MedSun has received 41 adverse event reports associated with Anesthesia or Analgesia gas machines manufactured by Draeger Medical GmbH; GE Healthcare, a division of General Electric Company; Mindray DS USA, Inc; and Spacelabs Healthcare, LTD. The reports were submitted by 26 hospitals between November 2008 and November 2010.

The four most commonly reported problems were :
• Device displays error messages (11 reports)
• Device inoperable (10 reports)
• Sensor Issue (6 reports)
• No display or display failure (5 reports)

The following were the patient outcomes for the remainder of the reports:
• Manual ventilation required (5 reports)
• Breathing difficulties (1 report)
• Cyanosis (1 report)
• Insufficient, light or patch anesthesia (1 report)
• Low oxygen saturation (1 report)
• Prolonged surgery (1 report)
• No consequence or impact to patient (14 reports)

Of the reports that listed patient age, three had a patient age listed as less than 21 years and twenty-five had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of twelve reports involved female patients and a total of sixteen reports involved male patients.

These MedSun reports, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recall(s) are associated with Anesthesia or Analgesia gas machines. The Medsun Reported events may, or may not, be involved in the recall(s) listed.

Recall 1: Class 2 Recall Aisys
Date Posted: June 23, 2009
Recall Number: Z-1425-2009
Product: GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.
Code Information: Please see link for a complete list of serial numbers affected.
Recalling Firm/Manufacturer: GE Healthcare; 9900 Innovation Drive Mail Stop: RP2138 Wauwatosa, Wisconsin 53226
Consumer Instructions: Contact the recalling firm for information
Reason for Recall: Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch.
Action: GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.
Quantity in Commerce: 3082

~~~

Recall 2: Class 2 Recall Fabius GS
Date Posted: September 23, 2010
Recall Number: Z-2478-2010
Product: Fabius GS Anesthesia Machine,
OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 inhalation anesthesia machine for use in operating, induction and recovery rooms
Code Information: catalog #8604699
Recalling Firm/Manufacturer: Draeger Medical Systems, Inc. 3135 Quarry Rd Telford, Pennsylvania 18969-1042
Consumer Instructions: Contact the recalling firm for information
Reason for Recall: Potential failures to Electri-Cord Manufacturing AC power cord
Action: Draeger Medical, Inc., sent an Urgent - Medical Device Recall letter dated August 2010 to all customers. The letter described the product, the problem, and actions to be taken by the customer. Customers were instructed to: 1) Immediately take the cord out of service if the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear. 2) Monitor the affected cords regularly and be mindful of excessive wear and tear, misuse, or abuse until the affected cord is replaced. 3) Customers were also asked to complete and return the enclosed Customer Power Cord Form via mail: Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969; fax: 1-215-721-5808; or e-mail: kathy.benedetto@draeger.com. 4) Disable the cords by cutting off the plug and dispose of the cord in accordance with their facility's disposal procedure when affected power cords are removed. NOTE: The firm will send replacement power cords free of charge. Draeger will only replace power cords originally provided by Draeger (identified with the white flag/part number 4117266. If you have any questions regarding this letter please call 1-800-543-5047 (press 1 at the first prompt, 2 at the second prompt and then 32349#).
Quantity in Commerce: up to 1973 products (GS & Tiro)

~~~

Recall 3: Class 2 Recall GE Datex-Ohmeda Aisys Anesthesia System
Date Posted: October 06, 2010
Recall Number: Z-0008-2011
Product: GE Datex-Ohmeda Aisys Anesthesia
System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE,
Finland
Code Information: Please see link for a complete list of serial numbers affected.
Recalling Firm/Manufacturer: GE Healthcare, LLC
3000 N Grandview
Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions: No consumer action necessary
Reason for Recall: Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient.
Action: GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.
Quantity in Commerce: 3039

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Recall 4: Class 2 Recall Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds
Date Posted: August 24, 2010
Recall Number: Z-2263-2010
Product: Philips M1013A IntelliVue G1
Anesthesia Gas Modules with manifolds
Code Information: Serial Number range ARYE-0014 to
ASBC-0013
Recalling Firm/Manufacturer: Philips Healthcare Inc.
3000 Minuteman
Road
Andover, Massachusetts 01810
Reason for Recall: The manifold seal in the Philips M1657B Water Trap used on the Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas Modules M1026B/BT may be unintentionally removed when changing the traps. A missing seal may result in leakage and may cause incorrect monitor readings of inspiratory or expiratory gas levels.
Action: Philips Healthcare issued an "Urgent Device Correction" letter dated July 14, 2010 with an addendum to the Instructions for Use including additional instructions for the replacement of the water trap for the Philips M1013A IntelliVue G1, M1019A IntelliVue G5, M1026B/BT Anesthesia Gas Modules. This addendum is being sent along with the Urgent Medical Device Correction notice to all affected customers. Customers will be requested to incorporate the information contained in the Urgent Medical Device Correction notice and the Addendum to the Instructions for Use with the existing labeling (Instructions for Use) provided with the product. Customers can contact Philips at 1-800-722-9377 for further information..
Quantity in Commerce: 531 units

~~~

Recall 5: Class 2 Recall BleaseSirius Anaesthesia Machine
Date Posted: July 29, 2010
Recall Number: Z-2113-2010
Product: leaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room.
Code Information: Serial numbers:
DOMESTIC - SIRI-001818, SIRI-001819, SIRI-001821, to SIRI-001829, SIRI-001851, SIRI-001852, SIRI-002081, SIRI-002082, SIRI-002085, SIRI-002089, SIRI-002091, SIRI-002097, SIRI-002099, SIRI-002101, SIRI-002102, SIRI-002106, SIRI-002108, and SIRI-002292.
INTERNATIONAL - SIRI-2302, SIRI-001611, SIRI-001612, SIRI-001614 to SIRI-001617, SIRI-001785, SIRI-001786, SIRI-001846 to SIRI-001850, SIRI-001853, to SIRI-001855, SIRI-001857, SIRI-001858, SIRI-001861, SIRI-001862, SIRI-001911, SIRI-001903 to SIRI-001905, SIRI-001921, SIRI-001948, SIRI-001949, SIRI-001950, SIRI-001951, SIRI-001952, SIRI-001954, SIRI-001961, SIRI-001963, SIRI-001964, SIRI-002041, SIRI-002135, SIRI-002139, SIRI-002150, SIRI-002156, SIRI-002157, SIRI-002159, SIRI-002162, SIRI-002166, SIRI-002168, SIRI-002169, SIRI-002171, SIRI-002201, SIRI-002224. SIRI-002298, SIRI-002304, SIRI-002315,SIRI-002349, SIRI-002354, and SIRI-002363.
Recalling Firm/Manufacturer: Spacelabs Healthcare, Llc 5150 220th Ave Se Issaquah, Washington 98029-6834
Reason for Recall: Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop.
Action: On 06/24/2010, Spacelabs began mailing the URGENT-MEDICAL DEVICE CORRECTION letter to their US consignees and e-mailed the same letter to their foreign consignees. The letter describes the touch screen of the BleaseSirius Anesthesia machine goes blank when touched and the possibility that this failure may cause the mechanical ventilation to stop. The consignees are asked to weigh the benefits versus the risk when deciding to use the device or not until the firm upgrades the device. The letter also instructs the consignees to notify their staff about the possibility of the display failure to prevent any adverse event that may occur. The letter states that their field service engineer will contact consignees to schedule a time to visit and upgrade all affected devices at no cost. The US consignees are advised to call 1-800-522-7025, Select 2, and the foreign consignees are advised to call 1-425-657-7200 x5089 for technical support or questions regarding the recall.
Quantity in Commerce: 80 units total

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Recall 6: Class 2 Recall Anesthesia system
Date Posted: April 16, 2010
Recall Number: Z-1408-2010
Product: The BleaseSirius and BleaseFocus
Anaesthesia Systems.
Code Information: Serial numbers:
Siri 000116, Siri 000885, Siri 001100, Siri 001609, Siri 001610, Siri-001618, Siri-001626, Siri-001637, Siri-001640, Siri-001644, Siri-001658, Siri-001666, Siri-001667, Siri-001668, Siri-001674, and Siri-001681. Focu-000735, Focu-000737 to Focu-000751, Focu-100001, Focu-100003 to Focu-100009.
Recalling Firm/Manufacturer: Blease Medical Equipment, Ltd.Deansway, Chesham Bucks, England
Reason for Recall: Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.
Action: On 2/26/2010 notification letters were sent to all international consignees. The 2 domestic consignees were sent notification letters via FEDEX on 3/26/2010. The domestic consignees were also contacted by phone on 3/26/2010. The notification letter is titled URGENT MEDICAL DEVICE CORRECTION. It advises users of the issue and provides additional information which would permit the continued use of the Blease system until replacement back bar valves can be fitted by the recalling firm's service representatives. For users who choose to continue to use the device, the manufacturer recommends the use of an Agent Monitor and user education; also checks that vapourisers have been mounted correctly and the system is leak free, and testing in advance of a procedure. For additional questions, US Customers are directed to call Global Technical Support - +1 425-657-7200 ext: 5089. Non US Customers, call Global Technical Support - +44 1494 784422.
Quantity in Commerce: 40 units

~~~

Recall 7: Class 2 Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
Date Posted: April 08, 2010
Recall Number: Z-1313-2010
Product: Datascope AS3000 Anesthesia System;
Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
Code Information: Product numbers 0998-00-3024-01.
Recalling Firm/Manufacturer: Mindray DS USA, Inc., dba Datascope Patient
Monitoring800 Macarthur BlvdMahwah, New Jersey 07430
Reason for Recall: An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.
Action: An "URGENT PRODUCT FIELD CORRECTIVE ACTION" letter dated March 5, 2010 was sent certified mail to all facilities/customers that have the AS3000 units. The letter described the product, problem and corrective Action/remediation by the firm. A Mindray Service Representative will contact the customers to arrange for the caster mounts to be replaced on the AS3000 units in their facilities at no cost. If you have any questions, please contact Karen Maine of the Mindray DS USA, Inc. Marketing Department at 201-995-8612 or k.maine@mindray.com.
Quantity in Commerce: 372 units in US, 107 internationally.

~~~

Recall 8: Class 1 Recall GE Aisys
Date Posted: May 11, 2010
Recall Number: Z-1526-2010
Product: GE, 1011-9000-000 Aisys Anesthesia
Machine and Monitor
Code Information: Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830 to ANAN00839, and ANAN00873.
Recalling Firm/Manufacturer: Ge Healthcare, Llc3000 N Grandview BlvdWaukesha, Wisconsin 53188-1615
Reason for Recall: Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
Action: Consignees were sent a GE Healthcare" Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Quantity in Commerce: 15 (OUS)

~~~

The following table lists the MedSun reports that are described in the device problem summary above. The reports have been edited for clarity.

Adverse Events
ManufacturerProduct Model Number Catalog Number Event Description
Draeger Medical Fabius GS * * Towards the end of a pediatric dental procedure, the anesthesiologist observed a message on the Drager Fabius GS anesthesia machine "flow sensor failure". He unplugged the flow sensor cable and then reconnected it. He called for biomedical engineering. The flow sensor was then glowing red and smoking. The procedure had already been completed and the pt was being moved out of the room. On examination of the sensor after the incident, it was noted that the plastic sensor cartridge was blackened, melted in places and the sensing electrodes inside it were black.
GE Medical AISYS Carestation S5 AISYS NA During a scheduled preventive maintenance inspection, it was noticed that there was rust on the rod of the bag/vent switch assembly. The assembly was replaced with a new part.
GE Datex-Ohmeda Anesthesia Unit S5 AISYS * During a scheduled preventive maintenance inspection, it was noticed that there was rust on the rod of the bag/vent switch assembly. The assembly was replaced with a new part. The suspected part was sequestered. This is the second time this event has occurred.
GE Medical S/5 AVANCE AVANCE Carestation * During a cardiac procedure on an infant with an interrupted aortic arch defect, the inspired CO2 reading on the anesthesia machine started rising to the mid 30 mmhg CO2. The patient was under pressure support ventilation on the anesthesia machine's ventilator. The patient's PCO2 was starting to give readings above 100 mmhg and physician was concerned about respiratory acidosis occurring. The physician then exchanged the ventilator to a stand alone vent and was able to get the inspired CO2 to drop in pressure support ventilation on the exchanged ventilator. Physician noted to biomedical that elevated inspired CO2 readings were occurring frequently during pressure support ventilation on all the anesthesia machines while ventilating infant patients and neonates.
GE Medical * * Power switch caused machine to shut down. Had to change out machine in middle of surgery. This has happened in the past and GE related to us that they are having trouble with the power switch failing. GE advised us that when this is going to occur that the machine will give a visible display that it is going to shut down in 8 seconds. Then we should turn the switch to standby. Once the machine shuts down - wait for 10 seconds until compressed air is heard. Then the machine will reboot itself.
GE Medical AISYS Carestation AISYS * In the middle of the case the patient had to be bagged while the anesthesia delivery machine was changed out. The switchout involves a change in circuits and a pedi-lite sensor. Anesthesiology was not aware that an upgrade for the carestation anesthesia delivery system was needed to take care of smaller children. We bought our machines at different times. The first ones were sent with the upgrade by mistake. The next order was not.
GE Medical S5 AISYS S5 AISYS NA "Vaporizor failure" shows on screen. No longer shows a vaporization concentration on screen. Surgeon gives estimate of 5-10 minutes to end. Switch to IV propofol for anesthesia to finish case and reduce fresh gas flow to minimize wash-out of sevoflurane. Extubate patient at end and take him to PACU breathing well, awakening.
GE Medical AISYS * * Anesthesia machine gave notice of impending shutdown in 8 seconds, while case was underway. It shut down and indicated to cycle the power switch. The machine came back on but no information was coming from gas analyzer. Display indicated device zeroing and warming, but did not achieve zero. Clinical engineering replaced gas analyzer at that time and replaced entire anesthesia machine at end of case. At the time of this entry a GE technician has evaluated the machine and replaced the suspected defect, a power switch.
GE Medical AISYS Carestation * * Could not properly ventilate a patient that was under general anesthesia for a procedure. The ventilator could not deliver the set tidal volume. Set tidal volume was ~ 700ml and unit was showing delivering ~ 100ml. It appeared that the flow sensors were not measuring inspiratory/expiratory volumes, or that there was a major leak that was missed. The following alarm messages appeared on the ventilator screen: "reverse exp flow. Check valves OK?" and "system leak?" Biomed was called for help. Machine was checked for leaks, but nothing was found. While the patient was ventilated with an ambu bag, the flow sensors were replaced without improvement. The condenser was checked and was emptied. It contained a lot of water. The machine was shut down and rebooted and the problem persisted. Finally the flow sensor module was disconnected and reconnected for a second time and the problem disappeared. However, this flow sensor issue has been happening for at least several months, multiple times with several Aisys machines at our facility. Usually the tidal volume readings are in accurate and flow sensors are swapped out intraoperatively or if unable to resolve the issue, the entire machine is swapped out.
GE Medical AISYS Carestation S5 AISYS * During a scheduled preventive maintenance inspection, it was noticed that there was rust on the rod of the bag/vent switch assembly. The assembly was replaced with a new part. The suspected part was sequestered.
Draeger Medical Fabius GS Fabius GS * Found a trend where the clip adapter is coming loose on the soda lime canisters. In both cases found soda lime canister not connected properly and clip adapter loose on the floor.
GE Medical Datex-Ohmeda S/5 * * Gas monitoring problems detected. On the display showing gas information, the displayed numbers went blank intermittently. No patient harm. Biomedical engineering contacted and worked with manufacturer to perform a factory reset. The reset involved clearing the anesthesia unit's memory, then reloading all the default information and checking for proper operation. The reset did not correct the problem, as it recurred as an intermittent problem thirteen days later. At that time, the factory service technician, working with our biomed department, replaced the display and the circuit board which feeds the gas information to the display. The problem has not returned since.
GE Medical AISYS * * Patient was status-post aortic root hemi-arch repair and had a mediastinal hematoma. Patient was brought to the or for re-exploration and evacuation of hematoma and repair of annular bleeding. Prior to the surgery the patient may have had hypoxic ischemic encephalopathy. During the preparation for the surgery it was noted that the patient was turning cyanotic and there was no saturation monitoring pick-up. The tidal volume on the anesthesia machine was set for 800cc but when the patient became cyanotic it was noted that the bellows were not pushing 800cc. The patient was taken off the anesthesia machine and was hand bagged with 100% oxygen until he recovered. He was placed back on the anesthesia machine and there were no further issues. During resuscitation the surgeon performed open cardiac massage.
GE Medical AISYS * * Patient under anesthesia in or for redo of coronary artery bypass x3. Prior to start of surgery it was noted that the ventilator on the anesthesia machine set to deliver 850cc of tidal volume but bellows would only push 400cc. Tubings changed, flow sensors changed but did not resolve problem. Pt was hand bagged while anesthesia machine was changed out. Surgery delayed but no patient injury.
GE Medical AISYS * * Patient in OR for thoracotomy. During the surgery it was noted that the anesthesia machine ventilator was set to deliver 450cc of tidal volume, bellows appeared to be delivering such but return volume was only reading 50-300cc. Flow sensors were changed numerous times but continued to be a problem. Patient blood gases were monitored during the procedure and appeared to be within normal limits so machine was not changed out. There was no patient harm.
GE Medical Datex-Ohmeda ADU * * System error on machine during turnover of operating room between 1 case and the next one. No patient involved. "Unexpected reset"
GE Medical Datex-Ohmeda S/5 ADU * * Between operating room cases an "unexpected reset-system failure" occurred.
GE Datex-Ohmeda Datex-Ohmeda ADU Carestation ADU * Just after patient was intubated, anesthesia machine shut down and was not working. A new machine was brought into the room and exchanged while the patient was ventilated from an oxygen tank.
GE Medical AISYS AISYS * In middle of the anesthetic, the Aisys machine displayed the warning "Calibrate flow sensors". To perform this calibration, the flow sensor assembly needs to be withdrawn from the machine and reinserted, and I did this. While performing this task the flow sensor connectors became disconnected. I could not replace the flow sensor connectors - both the need to reinsert the connectors into a holding device and the correct position up/down within the holding device were unclear. Therefore we were left with a non-functioning anesthesia machine in the middle of the anesthetic. In order to preserve the patient's safety, we got the emergency bag-valve-mask device and began to deliver ventilation. Biomed engineers were called. Emergency ventilation was performed. To avoid patient awareness and pain, anesthesia was replaced with propofol, since the sevoflurane anesthesia was being removed by the manual resuscitator that can deliver only oxygen. Sevoflurane anesthesia was reinstituted once the anesthesia machine was put back together and was functional again. Emergency actions were successful and patient safety was maintained. She had no vital signs perturbation or desaturation, and afterwards reported no intraoperative awareness.
Draeger Medical * * * During case, anesthesia machine faulted with a # 9 code. Dr looked at manual, and started to run through settings to repair the fault # 9. The machine shut down. Patient hand bagged throughout the rest of case. Drager medical called and reported. Mfr's rep will be in today to look at problem. Patient was transported to PACU after the surgery was completed with a oxygen saturation of 86-89%. The patient was discharged from PACU in stable condition with spontaneous respirations and oxygen saturation of 100%.
GE Datex-Ohmeda AESTIVA 3000 AESTIVA 3000 UNKNOWN While patient was undergoing hernia repair, anesthesia machine failed. Patient was ventilated manually for a few breaths and then allowed to breath spontaneously for the remainder of the case. No adverse impact on patient.
GE Datex-Ohmeda * * * Flow sensor failed, giving alert message "replace flow sensor" replacement sensor also failed. Multiple sensors from the same lot number have the same problem. This resulted in significant disruption of the surgical procedure and required hand ventilating the patient for about 10 minutes while the various components of the machine were exchanged.
GE Medical Anesthesia Machine AISYS * APL (adjustable pressure limiting) valve came loose from anesthesia machine while being adjusted.
GE Medical Datex-Ohmeda ADU * Patient was asleep in the or during a surgical procedure. Hospital experienced power surge due to a transformer blowing outside of OR. Patient began moving around. Discovered anesthesia gas administration disrupted. Patient's safety protected. Anesthesiologist put patient back to sleep. Patient has no recollection of event.
Draeger Medical NARKOMED 2B * * Surgical procedure being performed. Anesthesia machine set to deliver 12% desflurane and according to the monitor the patient was only receiving 6% and was showing signs of waking. Machine did not alarm.
Draeger Medical Apollo * * O2, N2O and AGT (agent) reading disappeared from display, and would intermittently return. Replaced and tested PATO sensor head, unit returned to service.
Draeger Medical Apollo Apollo * Anesthesia machine was found waiting for inspection/repair with a user's note attached that implied an O2 sensor problem. Initial testing by biomed technician identified a failure of gas analyzer and O2 sensor. Replacement part (PGM assembly) was ordered. Later the same day, technician repeated the test and all results were ok. Technician then set machine to monitor 100% oxygen (machine's O2 sensor indicated 97%) for 22 hours. When checked at end of test, machine's O2 trend showed a brief drop to 78% at one point, then recovery to 100%. PGM assembly was replaced as a precautionary measure. All subsequent tests passed, and machine was returned to use.
GE Medical AISYS * * An anesthesia machine in the operating room (OR) had a leak in the carbon dioxide absorbent connection. The rubber ring fell out of place.
Draeger Medical Apollo Apollo * An upgrade of our Compurecord patient charting program from version D.02 to F.00 was necessary to allow operation with Baytech's new model DS3 acquisition unit. (our existing M4 and M8 models are no longer available.) After the upgrade was completed, users reported that a "Comm port 1 fail" error message was occurring periodically on the anesthesia machine. It was determined that on Apollo anesthesia machines using the M4 or M8 units, the "Comm port 1 fail" message was displayed briefly at ten second intervals, although the actual patient data acquisition and recording seemed unaffected. For Apollo machines using the DS3 unit, there is no error message, but the acquired patient data in the Compurecord chart appears for 15 seconds and disappears for 30 seconds, producing periodic gaps in the patient's saved data record.
GE Medical S/5 AVANCE Carestation S/5 AVANCE Carestation * While transporting an anesthesia machine back to surgery, the right rear caster threaded stem snapped and the machine tipped to the floor, causing extensive damage to machine and accessories. Staff was not injured in this event. Staff noted that machine was rolling smoothly prior to wheel separation.
Spacelabs BleaseSirius BleaseSirius * I am writing to report an anesthesia machine malfunction that occurred in the OR this month. This case involved a small infant. The dialed tidal volume was 60 ml and the machine was registering 100ml, 120 ml and at one point over 2000 ml. There was a problem with the ETCO2 reading, too, with readings ranging from 40 to 100. There was also CO2 rebreathing. The sodalime cannister was changed out when the inspired CO2 was reading 6. It seemed to resolve the problem initially but then started giving readings of up to 19 with the ETCO2 showing 73-77.
GE Medical Datex-Ohmeda AS/3 ADU * ETT was hooked to anesthesia machine. Patient was induced. After 5 minutes of normal function, the machine suddenly gave a message stating "unexpected re-set, call for service." machine continued operating under existing settings, but now you cannot see or adjust the ventilator settings. Screen is stating message instead of vent settings etc. Other parts of anesthesia machine were working: cardiac monitoring; blood pressure; end-tidal CO2; and expired anesthesia gas levels. Able to continue the case without using the ventilator settings. Anesthesiologist obtained loaner from GI lab as standby. Case was able to be completed successfully. Patient extubated. Machine re-programmed itself after the procedure when reset by anesthesiologist. Problem did not recur. Anesthesiologist was unable to reproduce the failure after the procedure.
GE Medical Aestiva 5 * In the morning, the biomed responded to a problem in the OR. Aestiva ventilator stopped. Dr. was manually bagging patient. Aestiva ventilator had a warning message, prompting user to push knob to acknowledge vent had experienced a problem. Doing this cleared the message and allowed the user to return to ventilator mode, however, the problem reappeared after a few minutes.
GE Medical Aestiva * * Elderly female patient taken to or for total knee procedure. It was reported by the anesthesia tech that the Datex Ohmeda Aestiva-5 anesthesia machine had encountered problems. It was noted the bellows on the machine were not rising appropriately. Back up machine was obtained and switched out with original machine with no further reported issues with either the 2nd machine or the patient. Anesthesia tech reports upon troubleshooting the issue it was noted the machine had an excessive amount of dust originating from the CO2 absorbent canister. We have reported this problem with this product previously but this is the first time it has directly affected patient/procedure. Our hospital had determined we would not be using this product as soon as the replacement product we had found (Amsorb plus) arrived at our hospital. Our facility has now just learned the supplier of Sodasorb has now determined they will not be ordering from this particular vendor anymore and will be returning to their original product (Medisorb) which had been discontinued. No injury to patient, just a delay in procedure with having to switch to an alternate machine and an impact of time as it took our anesthesia staff time to clean large amount of dust out of machine and run machine through its paces before feeling secure enough to return it to service.
Mindray DS USA AS3000 Anesthesia Delivery System AS3000 * There was no patient harm. The MD was unable to turn on the ventilator. The ventilator screen turned off. Pt had to be manually ventilated.
Mindray DS USA AS3000 Anesthesia Delivery System AS3000 * No pt harm. The ventilator screen darkened and the vent turned off. The pt was manually ventilated.
Mindray DS USA AS3000 Anesthesia Delivery System AS3000 * Ventilator panel of anesthesia machine went blank and was inoperable.
MINDRAY DS USA AS3000 Anesthesia Delivery System AS3000 * Bellow of the anesthesia machine was not arising to the top even though tidal volume was delivered.
GE Datex-Ohmeda ADU Carestation S/5 * Anesthesia delivery unit stopped ventilating patient, CRNA certified registered nurse anethesthetist and SRNA student registered nurse anesthetist had to hand ventilate until new machine could be brought into room. CRNA board runner located another machine and brought into room. Patient remained hemodynamically stable and amnestic throughout the change in anesthesia machine. Ventilator thought to have failed while changing between pressure control ventilation and volume control. Biomed reviewed error codes on machine. Contacted manufacturer and determined that the inspirational proportional valve needs to be replaced. Will repair and return to service.
GE Datex-Ohmeda ADU Carestation * * The anesthesia machine system check-out procedure was passed in am prior to start of the day's cases. During the first case, the ventilator turned on, but the CRNA certified registered nurse anesthetist noticed that bellows were not cycling. The case proceeded with manual ventilation and the machine was changed-out after the case. The patient suffered no adverse effects.
GE Datex-Ohmeda AISYS Carestation * * During a procedure, the anesthesia machine stopped working and gave a message "try another cassette, schedule service." this has occurred before with no problems found in the logs or VAP test. Machine passed all checks. The machine was turned off, then on again to clear and began working for the remainder of the case. The machine was changed out of the OR suite and replaced. There was no injury to the patients.

Additional Information:

Recall 1: Class 2 Recall Aisys. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79156.

Recall 2: Class 2 Recall Fabius GS. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94224.

Recall 3 : Class 2 Recall GE Datex-Ohmeda Aisys Anesthesia System. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94054.

Recall 4: Class 2 Recall Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93109.

Recall 5: Class 2 Recall BleaseSirius Anaesthesia Machine. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92556.

Recall 6: Class 2 Recall Anesthesia system. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90223.

Recall 7: Class 2 Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89325.

Recall 8: Class 1 Recall GE Aisys. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90650.

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Updated January 1, 2011

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