Highlighted Reports
MedSun: Newsletter #54, November 2010

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 August 1 through August 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: Absorbent, Carbon-dioxide
Manufacturer: GE Healthcare, Vital Signs, Inc
Brand: Sodasorb
Model#: M1173312
Lot#: C201-P133-08

Problem:
Our hospital had used a product from GE named "Medisorb" for a long period of time, with no issues or concerns. This product is a CO2 absorbent used in all of our anesthesia machines. In early July it was noted that our facility started receiving a different product from GE. Initially we returned the product thinking it was an error in ordering. We again received and returned the different product. Upon questioning, GE stated they had discontinued making Medisorb and that they had sent a letter which our Materials Management department did not receive. We have MULTIPLE concerns with the replacement product: 1. The lid to the canisters containing the sodasorb are not grooved in any way, they just sit on the base which allows the lid to "pop off" easily letting the toxic pellets into the operating rooms. 2. The top edge of the base portion of the canister has cracked in several instances which allows pressure leaks and EXCESSIVE amount of dust in the OR's. In the past 2 weeks our anesthesia machines have had to be repaired/cleaned twice due to excessive dust. The dust causes machine leaks, gets everywhere, on the machine seals and in the past it has even made it through the machine to the patient circuit. 3. The replacement product is not labeled with a product name. The canister just states Prepackaged cartridge, Original, Disposable. There also appear to be 2 lot numbers on the packaging with neither of them being located where the canister says "lot". One is printed in small letters running horizontally on canister...the other is around the upper lip of canister. 4. It is felt by anesthesiology staff that the Sodasorb heats to a much higher temperature than the original Medisorb and appears to need changing with higher frequency. It is also taking staff a large amount of time troubleshooting issues, safely removing excess dust out of the product without compacting the granules in an effort to maintain the utmost CO2 absorption. 5. We have been told other facilities have started voicing similar complaints and GE has been in contact with the manufacturer and it has been suggested that a movement for change may be starting. Our facility will NOT be using this product. We feel it is unsafe to our patients, our staff and our equipment. Both canisters are from same lot number. We are now trialing an alternate product from a different vendor.
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Manufacturer response for CO2 Absorbent Canister
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Multiple emails and meetings with product rep.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Maquet, Inc
Brand: Servo-i
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Problem:
Ventilator kept alarming. Unable to solve problem. Patient ventilator was found to be without circuit compliance turned on. Vent settings had to be increased for ventilator support since the compliance was turned off. We had to change the circuit and the expiratory cassette in order for the machine to pass the circuit compliance check. Investigation revealed that the Servo vent will discontinue the tubing compensation automatically if the circuit test fails. The only way to tell that it is off is the absence of gold stripes around the volume and a small "c" appears. It was very hard to see and read. It is also not described in the manual.
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Health Professional's Impression
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Poor design. The warning that the circuit compliance is off is not clearly stated in the manual. It is also very hard to read. A small gold/ amber line. The smaller "c" is on the third screen and not easily seen.
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Manufacturer response for Ventilator, Servo
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They are looking into our recommendations.

Device:
Type: Condenser, Heat And Moisture (Artificial Nose)
Manufacturer: Ventlab Corp
Brand: Heat Moisture Exchanger
Model: FH603008

Problem:
Our facility learned our usual Heat Moisture Exchanger (HME) filters were on backorder and was offered a compatible placement product from the manufacturer. The only difference was to be the addition of a sampling port but other than that all measurements etc should have been the same. These filters are used on every adult general anesthetic procedure at our facility. Replacement items were received at our facility on a previous date. A few days later, it was reported to our office the anesthesia tech attempted to place one of the new replacement filters onto the anesthesia machine and the item would not fit. Pictures were taken and multiple personnel witnessed the device not fitting onto the flow sensors of the anesthesia machine. Another filter was obtained and fit VERY snuggly onto the flow sensor but was able to be used safely. While troubleshooting this issue another anesthesia tech reported having trouble the day before with one replacement filter not fitting but threw it away and did not notify anyone at the time. It has been determined the replacement filters either fit appropriately, fit very tightly or don't fit at all. No injury to patient, just delay in set up, and concern with work around in general. All anesthesia techs have been notified to watch for this concern and report issues to our office until our original product is available. Of note: An additional concern has been identified. The plastic packaging on the device does not state a lot number or expiration date. The cardboard box which the product is shipped in contains the only mention of a lot number, etc. These cardboard shipping boxes are not allowed in our inventory areas. Because of this, we are not able to include a lot number with this report and now have no way of knowing the lot numbers our facility received.
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Health Professional's Impression
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Does not fit appropriately. Measurements appear to be slightly different than what product information states.
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Manufacturer response for Heat Moisture Exchanger (HME) with filter and sampling Port, Tri-Anim
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Mfg. Rep met with our Materials Mgmt. staff to address concerns and find acceptable solution. Rep requested we save any involved items for return.


CARDIOVASCULAR

Device:
Type: Catheter, Ultrasound, Intravascular
Manufacturer: Volcano Corporation
Brand: Eagle Eye Gold

Problem:
Threading the Eagle Eye IVUS (intravascular ultrasound) catheter over the interventional wire (BMW) and the wire would not thread through the exit port. Cleaned wire multiple times - tried to thread IVUS catheter twice.


Device:
Type: Electrode Pad, Electrocardiograph, Adult
Manufacturer: ConMed Corporation
Brand: Ecg Backpad
Model#: 01-3130
Lot #: 1006041 2012-06
Cat #: 01-3130
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Problem:
A child with asthma and renovascular hypertension was admitted to the PICU for monitoring following aorto-renal bypass surgery lasting 2.5 hours. A note in the chart two days later indicated: "Patient was up and out of bed for the first time. Burn mark noted to the back from cardiac lead stickers from surgery. Practitioner notified; assessment was area in lower thoracic region has bubbling and some skin peeling noted." On first assessment, the practitioner thought that the area appeared to be either a reaction to or a skin burn from a bovie pad that was likely placed during the OR case. The area was approximately 8 inches by 10 inches in size; had blisters, then spread before skin sloughed off. The burn was treated with Meplex and healed. It was determined that there was no pooling of skin prep solution under the patient. There was no skin prep prior to placement of the backpad. This issue was investigated for the possibility of a radiation burn due to left renal angiogram with angioplasty 3 weeks prior. The patient was in interventional radiology (IR) from about 0840-1025. The radiation dose recorded by the IR staff for this renal angiogram was 164 uGy or 0.0164 rad. It is generally believed that no skin changes are seen at doses less than 200 rad. It is unknown if the warming blanket, coagulator pad/ESU could have contributed to the event. The patient was supine during surgery.


Device:
Type: Electrophysiology Recording System
Manufacturer: St. Jude Medical
Brand: Ep Medsystems
Model#: EP Med Software Version 4.1.0

Problem:
The electrophysiology (EP) four channel stimulator is connected to the EP Med recorder. During a ventricular tachycardia (VT) ablation, while pace-mapping, the EP Med froze and would not respond to the "HALT pacing" button on the keyboard. Pacing continued at rate of 250 ms (240 beats per minute) instead of stopping after three to four beats. While the EP Med system lagged, it continued to pace for four seconds, sixteen beats. The patient went into rapid, hemodynamically unstable ventricular tachycardia and required 200 joule external cardioversion. VT induced intentionally as a normal course of the procedure, but this specific episode was unintentional. The procedure continued as planned and the patient suffered no harm. This software "freeze" prevented the EP Med system from communicating with the EP-4 stimulator, so pacing could not be stopped using the usual "HALT" pacing keyboard button until the computer lag resolved (4 seconds later). The prolonged rapid pacing in the ventricle resulted in a VT that was accelerated from the patient's baseline VT and caused hemodynamic collapse.


Device:
Type: Hyperthermia Unit, Forced Air
Manufacturer: Arizant Healthcare
Brand: Bair Hugger
Model#: 505
Other #: Underbody Pad
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Problem:
Large rectangular erosion of back status post epidermal loss. Based on localized, rectangular morphology this is most consistent with an extrinsic thermal, ultraviolet radiation, or chemical factor that has led to epidermal necrosis and subsequent blister formation.
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Health Professional's Impression
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First report was that the burn was caused by an Arizant Bair Hugger
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Manufacturer response for Hyperthermia Unit, Forced Air, Bair Hugger (per the site reporter):
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Issue is around using these units on pediatric patients. In conversations with Arizant rep, they indicated that this unit should not be used on high. I asked if there was any labeling that they had to indicate this and they do not. The concern is that the unit could reach 56 degrees centigrade without shutting off.

The particular piece of equipment that was used on the patient was not identified. All units in surgery were evaluated and determined to meet manufacturer specifications.

My immediate concern is that these units have a maximum setting of 43 Degrees C. If the unit has a fault and continues to heat, it can reach 56 Degrees C. I believe this temperature is unsafe for infant/pediatric patients. There needs to be labeling by the manufacturer warning of using higher temperatures, or specific devices manufactured for this type of patient.


Device:
Type: Monitor, Blood Pressure, Transducer, Non-indwelling; Transducer, Blood-pressure, Extravascular
Manufacturer: Edwards Lifesciences
Brand: Pressure Monitoring Kit
Lot #: 58807471
Cat #: PXVK0831

Problem:
Anesthesia technician reports while getting ready for a CABG procedure she opened a new Pressure Monitoring kit and noted the high pressure tubing was disconnected from one of the transducer ports. Our office confirmed this is a connection site which should not come apart. This product was provided to us from the manufacturer as a replacement for a custom pressure monitoring kit which happens to be on backorder. We previously reported the same exact issue with our original product (PXVX225). Our anesthesia technician was told by the product rep that both broken kits had a "glue station" issue where one of the tubes going into a transducer did not adhere. The technician reports she replaced the damaged item with a new one from a different lot with no further issues or concerns.
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Health Professional's Impression
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It was broken upon opening.

See device image:
Photograph of Edwards Life Sciences Pressure Monitoring Kit, which shows the high pressure tubing disconnected from one of the transducer ports


GENERAL HOSPITAL

Device:
Type: Catheter, Implanted, Port
Manufacturer: Bard Access Systems
Brand: Powerport
Model#: Ref 1809600
Lot #: REUDO409

Problem:
After the port was inserted, the nurse was not able to aspirate blood. However, the port flushed with ease. 500ml of saline was infused and a cardiac drug was given. After infusing a portion of a unit of blood, the patient had swelling surrounding the port site. The transfusion was discontinued at that site and started in a peripheral site.
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Health Professional's Impression
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It was removed by the same surgeon. IV dye was used and it showed extravasation so another catheter was inserted. The surgeon was hopeful to only having to manipulate the catheter and possibly saving it and not having to reopen the pocket.



Device:
Type: Catheter, Picc
Manufacturer: Bard Access Systems Inc.
Brand: Sherlock Power Picc Double Lumen
Model#: 5 Fr. Double Lumen Basic Tray with MI
Lot #: REUA0530 and REUE 0882

Problem:
After placement of the Sherlock Power PICC, the chest x-ray showed a small wire in the pulmonary artery. This was removed by the Interventional Radiologist. The small wire was at the top of the stylet wire, which had separated from the rest of the wire. The tip has a small magnet added to it for tracking of the progression of the catheter as it is being inserted with the Bard Sherlock technology.
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Health Professional's Impression
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The stylet in the PICC magnet tip separated from the rest of the wire and embolized to the pulmonary artery requiring Interventional Radiology to place a line into the femoral artery and pull the piece of the stylet out.


Device:
Type: Fluid Warmer And Infuser
Manufacturer: Smiths Medical
Brand: Level 1
Model#: H250
Other #: 8000024

Problem:
Level 1 Infuser would not infuse blood into patient that had been involved in auto-pedestrian accident. Upon inspection by Biomed, it was noted that the gauge was broken and tubing on back of gauge had broken off. Different infuser brought to unit to continue treatment.
Patient had multiple rib fractures and scapular fracture, developed hemothorax requiring attempts at surgical decompression and repair but patient expired in operating room.
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Health Professional's Impression
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Blood could not be infused into patient - had to seek alternate device.

See device images:

Photograph of Smiths Medical infuser gauge that was broken.  Tubing on back of gauge had broken off.

Photograph of Smiths Medical infuser gauge that was broken.  Tubing on back of gauge had broken off.

Photograph of Smiths Medical infuser gauge that was broken.  Tubing on back of gauge had broken off.

Photograph of Smiths Medical infuser gauge that was broken.  Tubing on back of gauge had broken off.



Device:
Type: Light, Phototherapy
Manufacturer: GE Healthcare
Brand: Giraffe Pt Spot Light
Model#: 100-240VAC 50/60 Hz
Other #: Biomed Tag# 18677
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Problem:
The overhead fiber optic bililight made a loud popping sound and began to emit smoke. The light was turned off and unplugged from the outlet. It felt hot to the touch. The equipment was immediately tagged, removed, and sent to Biomed. Preventative maintenance was done two months ago. There was no harm to the patient. In addition, I was informed that it was the bulb inside of the light that went bad and actually popped and broke inside the light. It then emitted a burning odor, which may have been caused by the shards of glass inside. The glass did not reach the patient or staff. The light bulb was metered at 416 hours and typically is changed out at 500 hours. We have not had any other incidences of bulbs breaking. BioMed is reviewing their records as far as the age and number of the devices we have, and if we have any replacement parts in the device. Awaiting BioMed follow up.


Device:
Type: Needle, Hypodermic, Single Lumen
Manufacturer: Smiths Medical
Brand: Jelco Needle-pro
Cat #: 4292
Other #: 25g x 1" needle. Needle hub color is orange. A case is 8 boxes of 100.
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Problem:
Medical assistant (MA) was giving a minor patient a varicella vaccination into upper extremity and needle broke off at hub where the white part connects needle to bevel. Medication squirted all over patient, MA and counter. A new vaccination was drawn up and administered. The staff has been having issues with this brand of needles in that they come out of the person’s subcutaneous tissue, bent as well.


Device:
Type: Phototherapy, Neonatal
Manufacturer: GE Healthcare
Brand: Giraffe Spot Pt Light
Model#: 6600-0845-800
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Problem:
While doing repairs on an infant warmer, the clinical engineer noticed the Giraffe Spot PT light hanging on the side of the warmer had a brown area on the lens cover. After further investigation, the brown area appeared to be burned. The technician then went to the Newborn ICU and observed several other units with the same problem. Some of the covers observed were actually melted. It was noted during this investigation that several of these PT Spot lights are mounted to the sides of the open Ohio Infant warmer systems. The gooseneck of the lamps is swung so the lens is actually under the heating element of the warmer. This is causing the burn and melted areas on the lens covers. Clinical Engineering suggested to the department that these lights not be placed under the heating element. This practice has a potential for starting a fire.

Clinical Engineering suggested the goose neck on the light be moved so the lens cover is to the side of the warmer case and not below the heating element. These lens covers are made of plastic. The heat emitted from the warmer's heating element could cause burning and melting of the plastic.


Device:
Type: Urine Specimen Collection Cup
Manufacturer: BD
Brand: Bd Vacutainer
Model#: 364956

Problem:
There have been two occasions where the urine specimen cups had a sharp edge which resulted in the fingers or hands of the individual collecting the specimen to be nicked (skin tear) resulting in exposure to the patient's urine. Appropriate exposure protocol was initiated for the health care providers.


Device:
Type: Warmer, Infant Radiant
Manufacturer: Drager Medical
Brand: Babytherm
Model#: 8004
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Problem:
While in patient use, six of the nine Drager Babytherm 8004 infant warmers have had the hot side fuse holder burn up.


Device:
Type: Iv Tubing Set
Manufacturer: Carefusion
Brand: Alaris
Other#: 606-238-100

Problem:
The IV tubing formed a balloon. This has happened before.

Device:
Type: Iv Tubing, Vial Access
Manufacturer: ICU Medical
Brand: Genie
Lot#: 86-765-2A

Problem:
Three Genie Vial Access devices failed in IV Therapy clinic, all were the same lot number. One fell apart after being snapped in to vial. One had no spike on it - so could not be used, and one leaked 3-4cc of Etoposide out of the vial and on to the gloves of the person handling it and on to the mat in the hood.
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Health Professional's Impression
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Genie vial access devices are breaking, leaking and are coming out of the packaging with no spike.
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Manufacturer response for IV access device, Genie Vial access device
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No response from manufacturer


NEUROLOGY

Device:
Type: Motor, Drill, Pneumatic
Manufacturer: THE ANSPACH EFFORT, INC
Brand: Black Max
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Problem:
The exhaust gas line, which removes gas away from the pneumatic drill, ruptured during a craniotomy creating a loud bang in the OR. Several staff members complained of hearing loss immediately following the rupture. Injury is expected to be temporary.
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Health Professional's Impression
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High pressure build up in the exhaust hose. The hose did not have a pressure relief valve.
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Manufacturer response per the site reporter
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Anspach released a manufacturers letter in the spring of last year stating that they were upgrading to a new style hose that has a built in pressure relief valve. The manufacturer stated that new hoses and those needing repair would be fitted with this valve. There were no upgrades to older models unless they were in disrepair.


OBSTETRICS/GYNECOLOGY

Device:
Type: Disposable Vacuum Assist Cup
Manufacturer: OB Scientific
Brand: Gentlevac Vacuum Assist Cup
Lot #: 015031-1-1

Problem:
Gentle Vac was used to assist in the birth of the baby. This is not the standard or even second often used vacuum assist. The suction end has a plastic piece (disk) that should be removed prior to use. It looks differently than the other device's plastic pieces that need to be removed and not easily differentiated by staff. There is print on the removable disc stating to remove prior to use, but it is just raised print in the same color as the disk and difficult to see by staff. A picture is available (below). In this case the disk was not removed prior to use and when the baby was born the disk was on her head and left minor scratches.
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Health Professional's Impression
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The disk that should have been removed was not because it wasn't obvious based on the way it is designed and the less than easy to read print.

See device image:
Photograph of the Disposable Vacuum Assist Cup

RADIOLOGY

Device:
Type: Ct Scanner
Manufacturer: General Electric
Brand: Light Speed Vct
Model#: Light Speed VCT

Problem:
There was a repair necessary on the CT scanner. Originally, the engineer thought the tube was blown and, after it was replaced, he realized it was not the tube, but the tank. A tank was ordered and repairs were completed. Scans were performed for the following two days. Began noticing image quality issues on the second day. Contacted GE - engineer came in the next day and ran a QA scan. Found air bubbles in the oil line which was causing images to look as if there was pathology.

The engineer removed air bubbles from oil and ran another test scan, then turned the scanner back over to the department for clinical use.


Device:
Type: X-ray System, C-arm, Portable
Manufacturer: GE OEC Medical Systems

Problem:
Post procedure when archiving images to PACS/DR to be read, images or studies are discovered missing at which time Biomedical Engineering is notified. The procedural outcome has not been affected by this GE OEC recall.





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Special Note:
Lollipop Icon 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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