Highlighted Reports
MedSun: Newsletter #56, January 2011

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
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It is unknown whether the obvious glued welds could compromise the safety of the patient while under anesthesia.
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Manufacturer response for Heat Moisture Exchanger (HME) Filter, (brand not provided)
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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.
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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.
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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.
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Health Professional's Impression
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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.
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Manufacturer response per site reporter
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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.
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Health Professional's Impression
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Staff do not know.
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Manufacturer response for Flu vaccine syringe, Fluzone
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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.
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Health Professional's Impression
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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.
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Health Professional's Impression
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They appeared to be dull
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Manufacturer response for Dyonics Notchblaster (Peach) 5.5mm, Dyonics Notchblaster
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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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