Highlighted Reports
MedSun: Newsletter #85, June 2013

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 May 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.


Device:
Type: Bronchoscope (Flexible Or Rigid) ,Needle
Manufacturer: ConMed Corporation
Brand: Wang
Model#: MW-222
Lot #: 1205231
Other #: cytology needle

Problem:
During Bronchoscopy procedure Dr. inserted Wang Needle through scope for aspiration; upon retrieving needle through the scope, it became lodged at the end of scope. When he was able to pull catheter through the scope it was noticed that the needle was not attached. Needle was visualized with scope and many attempts were made to retrieve it. Patient was sent to cat scan to try and locate exact spot of needle; at the same time, the scope was processed and the needle was discovered to have been in the insertion tube on the scope and was collected during cleaning process.


Device:
Type: Implantable Cardioverter Defibrillator (Non-crt)
Manufacturer: Boston Scientific Corporation
Brand: Teligen
Model#: E110

Problem:
Patient with Boston Scientific Teligen ICD, Model E110. The patient has remote monitoring of device by Boston Scientific. He was notified that there was an alert indicated on the remote ICD monitor. The patient was brought to the ED by EMS. According to the EMS report, daughter told them that "pacemaker went off." Device interrogation by EP Nurse Practitioner the day after Boston Scientific's last recording showed "Voltage is too low for projected remaining capacity", while the battery status was falsely marked "OK." No shocks recorded. Patient denied chest pain, palpitations or shortness of breath. Boston Scientific Technical Support was called. Normal sensing and pacing. "Patient will require ICD generator change."

The patient underwent explantation of the old ICD and implantation of a new ICD generator as a result of this event.

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Manufacturer response for Generator (ICD), Teligen (per site reporter)
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Upon receipt at our Quality Assurance laboratory, this device was thoroughly inspected and analyzed. Review of the device memory confirmed low voltage battery faults had been recorded. External visual inspection of the device noted no anomalies. After the titanium case was opened, microscopic visual inspection did not reveal any irregularities. The battery was then removed, so that an external power supply could be connected to the device for further analysis. A higher than normal current usage was observed. Electrical testing isolated the high current condition to two compromised low voltage capacitors that are connected to the device's battery. This type of component malfunction can result in a high current drain, which over time can result in premature battery depletion, as was observed in this case.
COGNIS TELIGEN devices contain a coulomb counter, which is a continuously functioning current meter that tracks the energy being consumed by the battery. It measures charge rendered from the battery for low voltage functions. The battery management algorithm combines all its inputs to calculate remaining longevity, power consumption, and charge remaining and displays this data via the programmer summary screens. Any significant, unintended energy loss that is not measured by the device's internal coulometer will result in a premature drop in the monitored battery voltage. When the voltage drops below a set threshold for 3 days,the fault code will be issued by the device. The device will emit warning tones and a programmer will display a yellow fault screen upon interrogation of the device. For pts on the LATITUDE remote pt monitoring system, a yellow alert will also be generated. Although power measurements and battery capacity may appear normal via a programmer, the generation/appearance of this fault code indicates that some unknown amount of capacity was lost and the device may currently be depleting prematurely. Longevity calculations and battery status indications may not behave predictably after appearance of the fault code.
In this case, the longevity calculation and battery status did not reflect this loss of energy because the device was not in the latter part of its predicted life. As stated above, COGNIS TELIGEN devices will issue a fault code when the voltage level drops below a minimum threshold; this mechanism was implemented to ensure the battery voltage levels are monitored at all times/under all circumstances for these devices. It is important to emphasize that, based on review of the device memory, this device was capable of providing therapy while implanted. Conclusion: Confirmed product malfunction.


Device:
Type: Mesh, Surgical, Polymeric
Manufacturer: American Medical Systems, Inc.
Brand: Invance
Lot #: 687011
Cat #: 72403525
Other #: Perineal Sling

Problem:
Loose Perineal Sling which was excised. Urethral Stricture extending to the Prostatic Urethra just distal to likely Veru. Able to resect down to viable urethra to perform a primary repair. Fixed wide/patent bladder neck. while we were following our skin incision and during the process of dissection of the urethra, we came across the bone-anchored InVance sling which did not appear to be placing any tension on the urethra itself. The bone-anchored sling was completely removed.


Device:
Type: Prosthesis, Hip, Acetabular Liner
Manufacturer: Stryker Orthopaedics
Brand: Trident X332mm
Lot #: MKRP51
Cat #: 620032F

Problem:
Revision right total hip arthroplasty (head and liner exchange to constrained liner); Patient now five and half months status post revision of his right total hip arthroplasty acetabular component, now who has gone onto multiple dislocations, with only intermittent use of his abduction brace. It was clearly explained that each dislocation makes him more susceptible to a subsequent dislocation. Considering this, in conjunction with his intermittent abduction brace use, a revision surgery with constrained liner placement was offered to the patient.


Device:
Type: Prosthesis, Hip, Implant
Manufacturer: Stryker Orthopaedics
Brand: Lfit
Model#: 910650
Lot #: MKMPE4
Cat #: 013200

Problem:
Revision right total hip arthroplasty (head and liner exchange to constrained liner); Patient now five and half months status post revision of his right total hip arthroplasty acetabular component, now who has gone onto multiple dislocations, with only intermittent use of his abduction brace. It was clearly explained that each dislocation makes him more susceptible to a subsequent dislocation. Considering this, in conjunction with his intermittent abduction brace use, a revision surgery with constrained liner placement was offered to the patient.


Device:
Type: Pump, Infusion
Manufacturer: Smith's Medical
Brand: Medfusion
Model#: 3500

Problem:
Nurse was checking the syringe to see when it would be empty and need to be changed. It was expected to be low and it was found to have 13cc of solution in the syringe. The medication is Milrinone (0.1mg/ml). It was hung at 0300 and should have been running at 1.6cc/hour. If it ran at that rate for 12 hours there should have been about 1cc left in the syringe. Biomed was paged and they said they would not come and get the pump. Nurse supervisor said to place the pump in the dirty supply room, that biomed will look at it later. Medical team informed that Milrinone drip was not infusing for several hours ~ 7 hours.


Device:
Type: Radial Artery Catheterization Set
Manufacturer: Teleflex Inc.
Brand: Arrow Radial Artery Catheterization Set
Lot #: CF2125391
Cat #: RA-040201

Problem:
A 20 gauge Arrow catheter set was used to cannulate the patient's right radial artery. Once the artery was cannulated the white catheter was threaded into the artery. Unfortunately the catheter end was mostly occluded with white plastic (manufactured incorrectly) such that the arterial line tubing could not be attached to the catheter end. This resulted in unneccessary bleeding while additional equipment was being located and while troubleshooting was taking place. Once the problem was identified a new catheter had to be placed into the radial artery via a guide wire. And then the new catheter was successfully connected to the arterial line tubing.


Device:
Type: Replacement Heart-valve
Manufacturer: Edwards Lifesciences, LLC
Brand: Perimount
Model#: 3000
Other #: Size 23mm

Problem:
The patient underwent an aortic valve replacement with a pericardial valve sewn in place. The doctor noted it to appear to be well seated. The aortotomy was closed and the patient was re-warmed. After other procedural steps were also completed, the doctor noted that the transesophageal echo was difficult to evaluate the function of the valve prosthesis. Cardiology consulted and there was no evidence of any perivalvular leak, but there was moderate central aortic insufficiency. Patient was reheparinized, recannulated, placed back on cardiopulmonary bypass and the aortotomy was reopened. The aortic valve prosthesis was noted to be well seated, but it appeared to be almost prolapse of one of the leaflets of the prosthesis and central lack of coaptation. The valve was excised and a new valve was sewn in place. All three leaflets opened normally and looked to be of equal length and not one prolapsing as the first one did. The procedure was completed and the transesophageal echo was performed which showed there was normal function of the second valve. Patient impact: extended surgery approximately 101 minutes.


Device:
Type: Syringe, Piston
Manufacturer: BECTON, DICKINSON & CO.
Brand: Luer-lok
Model#: 309628
Lot #: 2236045

Problem:
The syringe was prepared and refrigerated in the Homecare Pharmacy. This was then stored in the patient's refrigerator for six days. The family member of the patient was adding the syringe of Vitamin K to the TPN bag in the patient's home and noticed there was a dark material inside the syringe. The syringe fluid is being cultured for bacteria and/or fungus but under the lab microscope, the material looks like a solid, crumbly black material. The syringe, solution and a remnant of the foreign object are retained here. Aerobic culture is negative but not finalized at 5 days. Fungal cultures are no growth to date. This event was discovered during the needle going into the TPN bag; it was not used or infused by the patient. There was no visible foreign object present when the medication was drawn up into the syringe.

All cultures have continued to be negative. We will be able to send the syringe back next week with the proper instructions. We have not received instructions from the manufacturer on sending this back yet.


Device:
Type: Ventilator
Manufacturer: Ventlab Corportation
Lot #: 22484
Cat #: VR6100
Other #: 710304N

Problem:
The anesthesiologist was in the process of placing the vent mask over the patient's mouth, when the patient said "There is something on my lip." A small clear circular piece of plastic was found that exactly matches the hole in the bag that contained the mask. The plastic was removed and anesthesia continued. The packaging is clear thin pliable plastic. The punched holes are approximately 9mm. This particular mask is from lot# 22484, but this probably involves multiple lot numbers.

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Manufacturer response for vent mask, vent mask (per site reporter)
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The rep has told the company. They do not plan to change the packaging design/process.


Device:
Type: Ventricular (Assisst) Bypass
Manufacturer: BERLIN HEART GMBH
Brand: Excor Pediatric
Model#: H100004

Problem:
Pt is on Berlin heart. The pt was noted to have poor ejection (<50% every beat.) No changes noted in hemodynamic status. Fluid levels and pressures were normal and unchanged. No harm was caused. Drive pressure and % systole were increased gradually from 190-250 and 36-50%. The driver was replaced with a backup driver to check integrity of compressor, but no improvement to ejection. Began hand pumping for approx 5 minutes when ejection became 0% every beat, no effect. Pump replacement ordered by CT surgeon. Pump was exchanged at ICU bedside.

Device:
Type: Warmer, Infant, Radiant
Manufacturer: GE Healthcare, LLC.
Brand: Giraffe Omnibed
Model#: 6650-0004-901
Other #: Warmer, Radiant/Isolette, Infant

Problem:
Giraffe bed alarmed for "fan malfunction" however, everything appeared to be functioning okay (appropriate heat output and baby's temp was fine). Bed turned off and turned back on. New error "system failure 25" noted on screen and bed would not function at all.
After Biomed investigated, we found the bearings of the fan motor were defective. This is the 6th one of these beds that have had this problem. We replaced the bearings and returned to service. We also checked with staff that perform the cleaning of the beds to make sure they were not causing liquid to enter into the fan motor bearings. Their cleaning method is fine, not getting liquid into the motor.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: FRESENIUS
Brand: Terumo Fresenius C. A. T. S.
Model#: CATS

Problem:
Problem: Loss of suction during critical aspects of a liver transplant with resultant inability to recirculate blood. This event has been experienced several episodes during a liver transplant where the system was incapable of keeping up with our blood loss during a liver transplant. When this system fails to work, we have to resort to standard suction which results in a significant amount of blood loss, that could have been recirculated, with an increase in blood useage, and a demonstrable negative impact to the patient. This failure of this system seems to be happening much higher frequency than seen before.

The systems works well for low volume heparinized blood loss. This would be the case that would occur during most cardiac cases and for most of our liver transplants since, in the majority of cases we lose very little blood. However when there is a "bleeder" there may be large volume non-anticoagulated blood loss. In this scenario, the canisters in the current system and the pumps cannot keep up and essentially, suction is lost - then the need to resort to wall suction.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: FRESENIUS
Brand: Terumo Fresenius C. A. T. S.
Model#: CATS

Problem:
Problem: Loss of suction during critical aspects of a liver transplant with resultant inability to recirculate blood. This event has been experienced several episodes during a liver transplant where the system was incapable of keeping up with our blood loss during a liver transplant. When this system fails to work, we have to resort to standard suction which results in a significant amount of blood loss, that could have been recirculated, with an increase in blood useage, and a demonstrable negative impact to the patient. This failure of this system seems to be happening much higher frequency than seen before.

The systems works well for low volume heparinized blood loss. This would be the case that would occur during most cardiac cases and for most of our liver transplants since, in the majority of cases we lose very little blood. However when there is a "bleeder" there may be large volume non-anticoagulated blood loss. In this scenario, the canisters in the current system and the pumps cannot keep up and essentially, suction is lost - then the need to resort to wall suction.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: FRESENIUS
Brand: Terumo Fresenius C. A. T. S.
Model#: CATS

Problem:
Problem: Loss of suction during critical aspects of a liver transplant with resultant inability to recirculate blood. This event has been experienced several episodes during a liver transplant where the system was incapable of keeping up with our blood loss during a liver transplant. When this system fails to work, we have to resort to standard suction which results in a significant amount of blood loss, that could have been recirculated, with an increase in blood useage, and a demonstrable negative impact to the patient. This failure of this system seems to be happening much higher frequency than seen before.

The systems works well for low volume heparinized blood loss. This would be the case that would occur during most cardiac cases and for most of our liver transplants since, in the majority of cases we lose very little blood. However when there is a "bleeder" there may be large volume non-anticoagulated blood loss. In this scenario, the canisters in the current system and the pumps cannot keep up and essentially, suction is lost - then the need to resort to wall suction.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: FRESENIUS
Brand: Terumo Fresenius C. A. T. S.
Model#: CATS

Problem:
Problem: Loss of suction during critical aspects of a liver transplant with resultant inability to recirculate blood. This event has been experienced several episodes during a liver transplant where the system was incapable of keeping up with our blood loss during a liver transplant. When this system fails to work, we have to resort to standard suction which results in a significant amount of blood loss, that could have been recirculated, with an increase in blood useage, and a demonstrable negative impact to the patient. This failure of this system seems to be happening much higher frequency than seen before.

The systems works well for low volume heparinized blood loss. This would be the case that would occur during most cardiac cases and for most of our liver transplants since, in the majority of cases we lose very little blood. However when there is a "bleeder" there may be large volume non-anticoagulated blood loss. In this scenario, the canisters in the current system and the pumps cannot keep up and essentially, suction is lost - then the need to resort to wall suction.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: FRESENIUS
Brand: Terumo Fresenius C. A. T. S.
Model#: CATS

Problem:
Problem: Loss of suction during critical aspects of a liver transplant with resultant inability to recirculate blood. This event has been experienced several episodes during a liver transplant where the system was incapable of keeping up with our blood loss during a liver transplant. When this system fails to work, we have to resort to standard suction which results in a significant amount of blood loss, that could have been recirculated, with an increase in blood useage, and a demonstrable negative impact to the patient. This failure of this system seems to be happening much higher frequency than seen before.

The systems works well for low volume heparinized blood loss. This would be the case that would occur during most cardiac cases and for most of our liver transplants since, in the majority of cases we lose very little blood. However when there is a "bleeder" there may be large volume non-anticoagulated blood loss. In this scenario, the canisters in the current system and the pumps cannot keep up and essentially, suction is lost - then the need to resort to wall suction.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: FRESENIUS
Brand: Terumo Fresenius C. A. T. S.
Model#: CATS

Problem:
Problem: Loss of suction during critical aspects of a liver transplant with resultant inability to recirculate blood. This event has been experienced several episodes during a liver transplant where the system was incapable of keeping up with our blood loss during a liver transplant. When this system fails to work, we have to resort to standard suction which results in a significant amount of blood loss, that could have been recirculated, with an increase in blood useage, and a demonstrable negative impact to the patient. This failure of this system seems to be happening much higher frequency than seen before.

The systems works well for low volume heparinized blood loss. This would be the case that would occur during most cardiac cases and for most of our liver transplants since, in the majority of cases we lose very little blood. However when there is a "bleeder" there may be large volume non-anticoagulated blood loss. In this scenario, the canisters in the current system and the pumps cannot keep up and essentially, suction is lost - then the need to resort to wall suction.


Device:
Type: Apparatus, Nitric Oxide Delivery
Manufacturer: Ikaria
Brand: Inomax Dsir

Problem:
Pediatric patient on Nitric Oxide being transferred from ICU to OR. While transferring pediatric patient to OR gurney, Inovent kept alarming. Upon checking, it read "Low NO Delivery Failure" and there was a big red X on the NO control dial on the screen. All machine connections and tank psi were checked & verified to be working. Pt's pulse ox dropped by 6 points from 83% to 77%. Immediately called for back up and a backup Inovent was connected. Patient's vital signs were otherwise unchanged during the approximately 1 minute time period of the failed machine. Failed machine then taken out of service.


Device:
Type: Cylinder, Compressed Gas
Manufacturer: Linde Gas North America LLC
Cat #: 109850

Problem:
Staff had difficulty removing the cap on the AGA Linde Healthcare Oxygen E cylinder resulting in slight delay of administering oxygen during an emergency event. The incident occurred around 0730 a.m. The cap on the oxygen nipple had changed for the oxygen e-cylinders that we receive. The older cap that was previously received was a slick black cap (structured: flexible with no hole on the end) that fitted on the regulator/O2 nipple and was easily removable. Now it is a sturdy dark grey cap (structured: sturdy, no hole on the end, which allows airflow through the cap) that is difficult to remove.

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Manufacturer response for Oxygen E-cylinder, (brand not provided) (per site reporter)
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•The new caps have been in use the past 3 – 4 months
•The change is due to a safety feature (will not pop off when valve is opened) and is in use industry wide
•The caps should pull off easily with two fingers. They can be twisted but it's not necessary
•They have not had this issue from any other customers

Here is what the compliance team's response is:

The capping of cylinder openings is not going to stop. You can contact your cap plugs rep and see if he can provide you with a cap that is easier for them to remove. You can also tell them that we are providing them a finished drug product and the caps are required per our internal procedures.

if you'd like further information on this, please call 866-543-3427 and file a formal complaint.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Draeger Medical, Inc.
Brand: Evita Infinity
Model#: EVITA INFINITY V500

Problem:
Respiratory Therapist reported: Vent flashed vs500 battery error when we tried to go on a road trip. Biomed engineer reported: It appears as the RT was disconnecting the high pressure gas hoses and power cord in order to take the patient to a procedure elsewhere, the vent generated a "GS500 Failure" alarm. I see where the RT stated "battery" within that text but the GS500 does not have a battery alarm related to it, and the alarm logs showed the GS500 alarm only. It was determined to be reportable as there was another vent that generated this same alarm under the same conditions.


Device:
Type: Ventilator, High Frequency
Manufacturer: Bunnell, Inc.
Brand: Life Pulse
Model#: 203

Problem:
The High Frequency Jet Ventilator (HFJV) started to alarm, the heater alarms were all flashing at once and the digital readout would turn off and on, BioMed and RT supervisor notified. The HFJV was switched out to a new one. Biomed investigated and was able to reproduce the problem. Unit is being sent back to the manufacturer for review.


Device:
Type: Dilator, Vessel
Manufacturer: Edwards Lifesciences LLC
Brand: Retroflex
Model#: 9100DKS7
Lot #: 59228494
Other #: Size #28 Fr

Problem:
Patient with severe symptomatic aortic stenosis was undergoing vascular access during a TAVI procedure. After intravascular ultrasound and measurement, a transfemoral approach was chosen for the TAVI. A cutdown was performed on the right common femoral artery. A sheath that had been previously placed was removed and a 5-0 prolene placed as a purse-string to control bleeding. Arterial access was obtained with a needle and a guide wire was advanced. An exchange catheter was used to change to a stiff guidewire. Arterial dilations were then started and resistance was encountered while using the #28 Fr dilator. The tip of the dilator sheared off completely and created an intravascular foreign body. The wire was still in position through the central lumen of the tip of the dilator sheath. A snare attempt to retrieve the foreign body from the opposite groin was not successful. When withdrawing the dilator sheath, an avulsion injury occurred to the right distal extenal iliac, proximal common femoral system. An open incision was then done to obtain proximal control and exposure of common iliac artery. The dilator and intravscular foreign body (piece of dilator) were then successfully removed. The artery was found to be avulsed in half and required extensive repair. TAVI procedure was not performed at this time due to the complication with the dilator.


Device:
Type: Instrument, Biopsy
Manufacturer: Medical Device Technologies, Inc.
Brand: Angiotech Biopince
Cat #: 360-1580-01

Problem:
The patient was scheduled to undergo a CT-guided medical renal biopsy. The biopsy needle (Biopince) needle misfired and left a piece of metal "sticking out of the needle." Because of the protruding metal, the needle was "unable to fit in the guide needle" and therefore did not obtain the needed specimen. Another device was utilized to complete the biopsy procedure. There was no injury to the patient.


Device:
Type: System, Dialysis, Crrt
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model#: Prismaflex

Problem:
CRRT Prismaflex machine started to alarm after 2100 - warning message said that System failure occurred. Disconnected patient from the unit without giving blood back to the patient as the machine was frozen on the "system failure occurred" screen. Turned off the machine and restarted it to remove the set. Approximately 1.5 hours of interrupted therapy. System failure for no apparent reason. Biomed unable to duplicate problem.


Device:
Type: Pump, Infusion, Implanted
Manufacturer: Medtronic Neuromodulation
Brand: Synchromed Ii
Model#: 8637-20

Problem:
Patient has a long history of chronic low back pain and is status post implantation of an intrathecal pump approximately 3 years ago. Patient has done well with use of intrathecal medications until recently when the pain became difficult to control. The patient also expressed discomfort with the positioning of the pump and its ineffectiveness at helping control pain. The physician began the weaning process from the pump when it began to stall, causing withdrawal symptoms. It was then decided to reduce the patient to a minimal rate and begin oral morphine. Patient returned to surgery for removal of the intrathecal pump and catheters.


Device:
Type: Device, Thermal Ablation, Endometrial
Manufacturer: BOSTON SCIENTIFIC
Brand: Genesys Hta Procerva
Model#: M006580210
Lot #: 45301
Cat #: 58021

Problem:
GYN surgeon was attempting to perform a hydrothermal ablation. It was discovered that the cassette on the disposable device was defective and was not allowing flow of saline. A new kit was opened. The procedure was then performed without incident.


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