Highlighted Reports
MedSun: Newsletter #65, October 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 July 1 through July 31, 2011. 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.


CARDIOVASCULAR

Device:
Type: Angiography Pack
Manufacturer: DeRoyal
Brand: Angiography Pack
Lot #: 25081847
Cat #: 89-7387.01
Other #: REF 89-7387.01

Problem:
While the RN was setting up the sterile field for a cardiac procedure, she opened a Angiography pack. She noted a dead worm in the sterile kit. The sterile field was torn down and set up again. No patient contact as incident happened before patient brought into room.
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Manufacturer response for Angiography Pack, Angiography Pack (per site reporter)
======================
Customer Service Representative was notified of incident.
QFI #22061. The manufacturer will send a replacement kit. Worm will be sent to manufacturer for investigation. Picture of worm available. Worm sent to the manufacturer.


Device:
Type: Catheter, Ablation, Cryo, Cardiac
Manufacturer: Medtronic, Inc.
Brand: Arctic Front
Lot #: 61588

Problem:
The sensor reading of the catheter read the temperature was too high and that blood was present within the catheter. This reading was not accurate as the system was made air tight and closed. Several attempts were made to rectify the issue including changing connectors to the catheter, reflushing the catheter to remove all potential air bubbles and testing the catheter outside the body in water. The balloon was also inflated to attempt cryofreezing, but these attempts were also unsuccessful in resolving the temperature error. A new Arctic Front ablation catheter was used in order to complete the procedure. There was no known injury to the patient.

Device:
Type: Catheter, Continuous Flush
Manufacturer: Boston Scientific Corporation
Brand: Renegade
Model#: M001282880
Lot #: 14097058
Cat #: M001282880

Problem:
Neuro Renegade Hi-Flo catheter was advanced over a Synchro-2 guidewire into the intracranial portion of the left vertebral artery and positioned in the left posterior cerebral artery for a Neuroform EZ stent placement. Initially a Neuroform EZ was prepped, but could not be advanced through the catheter. This was removed. Another Neuroform EZ stent was prepped. Again, this one could not be advanced through the catheter. The Neuro Renegade catheter was removed and there appeared to be a defect (kink) in the piece near the hub of the catheter.


Device:
Type: Catheter, Mapping, Cardiac
Manufacturer: Biosense Webster
Brand: Lasso 2515 Nav
Lot #: 15400161L
Cat #: LN222515CT
Other #: 35U251R

Problem:
During a complex A-fib ablation procedure, while the physician was positioning the Lasso catheter from left to right side of heart when the catheter became entangled in the tricuspid valve. Multiple attempts to remove the catheter were unsuccessful, the physician met resistance when trying to remove the catheter. The cardiovascular (CV) surgeon was called; a bedside 3D echo was performed. Per the surgeon's suggestion, the catheter was removed under echo guidance. Once removed, there was evidence of tissue on the tip of the catheter which was sent to pathology and identified as tricuspid valve tissue. There was no visible defect noted on the catheter itself. The patient was transferred to CICU. The patient was unable to go to surgery a week later, due to low platelet count. The patient requires an ablation, repair of shunt and tricuspid valve. The patient is currently on oxygen, is awake, and talking.


Device:
Type: Catheter, Percutaneous
Manufacturer: Arrow
Brand: Pressure Injectable Multi-lumen Cvc Kit
Model#: CDC-45703-XP1A
Lot #: RF1046257

Problem:
Patient with 35% total body surface burns on chest was undergoing line changes every three days. As the resident started to place the wire, it fractured and started to unravel underneath the patient's clavicle. The incision had to be extended in order to remove the wire. Other than the cut down, the patient had no other sequela from this incident.
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Manufacturer response for CVC Kit, Pressure Injectable Multi-Lumen CVC kit (per site reporter)
======================
Lot pulled from Central Distribution and units. According to an email received from the firm: "We went to the SICU and Burn unit to look for the lot number in question. No kits on either unit were found. We were able to find one case in CD. Arrow has issued a credit for return. We will send the UF another case to replace the lot number in question. UF uses 3600 triple lumen kits. UF has reported having 4 spring wire-guides (SWG) unravel within the last month. This is a less then 1% occurrence throughout the year. Based on that information it was most likely a bad lot of kits. The numbers also show that it is not a technique issue. If there are any other SWG issues please have the units keep the product as well as lid-stock."


Device:
Type: Catheter, Swan Ganz
Manufacturer: EDWARDS LIFESCIENCES, LLC.
Brand: Venous Infusion Port (Vip) Five Lumen
Model#: 831HF75
Lot #: 58971113

Problem:
The patient's Swan Ganz was attached to the GE Marquette monitor. The temperature reading was 104.0 degrees. When the temperature was taken temporally it registered at 98.2 degrees. All cables were changed and the module. This did not change the results. The patient was afebrile. Biomed was called in and the monitor was checked as well as modules and all cables involved. Equipment and cables were found to be in working order.
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Manufacturer response for Thermodilution Venous Infusion Port (VIP)Swan Ganz, Swan Ganz (per site reporter)
======================
Edwards Lifesciences is sending return box to hospital to have product returned to them.


Device:
Type: Compressor, Cardiac, External
Manufacturer: Physio-Control
Brand: Lucas 2
Model#: 100250-00

Problem:
An ICU patient in cardiac arrest had the LUCAS device applied for chest compressions per manufacturer's directions. It worked for approximately 2-3 minutes then stopped working. There was an audible alarm and the alarm button and 3rd battery indicator light turned red. The device turned off and then back on but continued to alarm and would not restart. The device was removed; manual compressions were restarted until a different device was available. When the audible alarm went off and the alarm light and 3rd battery indicator light turned red, the first 2 battery indicator bars stayed lit in green. The battery on this device is checked nightly to assure full charge at all times.
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Manufacturer response for LUCAS 2 Chest Compression Device, LUCAS 2 (per site reporter)
======================
"For the symptoms described, the technicians suggested to check for broken/smashed wires from the hood pressing down on them and the sharp edges of the boards. This has been known to cause these symptoms" - direct quote from sales rep e-mail to our BioMed dept. We have asked for loaners to replace so they can check these machines out themselves as this problem occurred in earlier this year as well.


Device 1:
Type: Defibrillator, Crt
Manufacturer: St Jude Medical
Brand: Unify
Model#: CD3231-40

Device 2:
Type: Lead, Defibrillation
Manufacturer: St. Jude Medical
Brand: Durata
Model#: 7120

Device 3:
Type: Lead, Left Ventricular
Manufacturer: St Jude Medical
Brand: Quickflex
Model#: 1258T/86

Device 4:
Type: Lead, Pacemaker
Manufacturer: St. Jude Medical
Brand: Optisense
Model#: 1699TC/46

Problem:
Patient with a history of nonischemic cardiomyopathy, left bundle-branch block who underwent implantation of a St. Jude biventricular ICD system which was complicated by lead dislodgement and pericardial effusion requiring pericardiocentesis as well as requiring extraction of all the leads and the pre-implantation of all the leads 3 days later along with the bi-ventricular ICD. There was improper pacing noted when the device was tested. Device programmer displayed error message ("atypical response"). The patient was admitted to the CCU and Medicine Cardiology Service on the day after the implant following hypotension and new-onset atrial fibrillation in setting of bi-ventricular ICD placement with RV lead displacement. Bedside echo revealed pericardial effusion, and given suspected tamponade physiology, patient was taken for urgent pericardiocentesis. The pericardiocentesis resulted in 180cc bloody fluid removal, and a pericardial drain was placed. The patient returned to the CCU for furthering monitoring. Upon return, the patient remained in atrial fibrillation with rapid ventricular response (HR 150s), thus was loaded with amiodarone and continued on an amiodarone drip. Later that evening, the patient was again noted to become hypotensive, with systolic blood pressures (SBP) 60s, although she remained asymptomatic throughout.

Two days after this episode, the patient returned to the EP suite for revision of the right ventricular (RV) lead. Extraction of right atrial (RA) lead, RV lead, and left ventricular (LV) lead was performed, with subsequent implantation of atrio-biventricular ICD system in the left pre-pectoral position. The pericardial drain remained in place, with close monitoring of output following. Patient remained hemodynamically stable, and was transferred to floor status the next day. The pulmonary artery (PA) catheter was subsequently removed. The patient was seen in clinic on over two weeks later, at that time, patient was feeling great.


Device:
Type: Defibrillator, External
Manufacturer: Philips Medical Systems
Brand: Heartstart Mrx
Model#: M3535A

Problem:
The unit (defibrillator) failed a self-initiated auto test which resulted in a functional lock-out and audible alarm occurring at 00:37am. The staff was not aware of the issue until 11:00am when they investigated the beeping alarm (the unit was in an E.P. Lab not in use that day). The unit (defibrillator) displayed a message: "Charge Shock Failure - Therapy PCA".

Biomed response was to verify the problem [running unit's (defibrillator) OpCheck (operational check/test) function did not clear symptom] and removal of the unit to Biomed. The battery was removed to silence the alarm. The symptom was observed multiple times in Biomed during the OpCheck function. The manufacturer was called and while on the phone they asked for the serial number [which is under a removable AC power supply]. After the AC power supply was reattached and an OpCheck performed the symptom cleared. We believe that a total power down reset occurred because the battery was still removed when the AC supply was removed. Not explained was the fact that the symptom persisted even after the unit was transported to Biomed with the battery removed and no AC power connected. The symptom cleared only after both the battery and the AC power supply was removed, followed by the OpCheck routine.

This unit was returned to the manufacturer for evaluation and their findings are not known at this time.


Device:
Type: Defibrillator, External
Manufacturer: Philips Medical Systems
Brand: Heartstart Xl
Model#: M4735A

Problem:
During a code blue the patient went into asystole, transcutanious pacing was started with success. The patient was intubated and regained a pulse with 100% pacing. While preparing to transport the patient to CCU, defibrillator was unplugged and moved off of the code cart to the bed. When the defibrillator was moved off of the code cart the battery came out of defibrillator and turned off the entire defibrillator. The battery eject button was accidently pushed in by the lip on top of code cart while defibrillator was being removed. The patient lost pacing and went back into asystole. The battery was shoved back into the defibrillator, the external pacemaker turned back on and the settings were restored with success of patient capture and resumed pacing the patient.

Over two years ago we contacted the manufacturer about this issue happening several times to us. They did not have a way to cover or protect the battery release button from accidently being activated. We ended up attaching material (plastic) to the bottom of the defibrillator to raise it up enough so the release button would be higher then the lip of the code cart.


Device:
Type: Hose, Nibp Adapter
Manufacturer: GE Healthcare
Brand: Critikon
Model#: 330062
Cat #: 330062

Problem:
The NIBP machine from a nursing unit was not working. The NIBP device was tagged and sent to biomed. The biomed technician called me to alert me to his findings. He stated that the entire NIBP tubing was filled with blood. We could not identify when this machine was taken out of service, which patient it was last used for and the staff member that used it prior to the dysfunction. There is concern that this product/device (NIBP hose adapter) fits our IV tubing connections. It does not have a unique fitting in order to prevent someone a
ccidentally attaching it to IV tubing.

When this event was brought to my attention, I removed an IV cap from an IV tubing injection site and was able to connect the GE/Critikon NIBP male slip Luer connector from the cuff adaptor to the injection site.

We do not know if this one was actually ever connected to the IV tubing; however we did discover that it was possible, which is a concern.


Device:
Type: Lead, Defibrillation
Manufacturer: St Jude Medical Cardiac Rhythm Management Division
Brand: Durata
Model#: 7120Q/58

Problem:
Primary prevention patient had ICD system implanted. The procedure was uneventful, post procedure stay uneventful, and was discharged to home the next day. The patient returned to the ED in the evening on the day of discharge. A lead perforation of the right ventricle was seen on CT scan. The next day, the patient was transferred to another facility for lead extraction with the procedure performed the following day. At that time a new lead was implanted.


Device:
Type: Monitor, Physiological, Transport
Manufacturer: GE Healthcare
Brand: Transport Pro
Model#: Transport Pro

Problem:
Team was transferring the patient from the Interventional Radiology (IR) table to the radiant warmer. The IR RN was moving the transport monitor to the patient's bed. The Tram housing (Tram chute) fell off the monitor (Transport Pro) and landed on patient's arm and chest. We have four of these type devices (monitors). We found 1 with a missing screw (that locks the Tram housing to the monitor) in April. Then we had this reported incident. Upon inspection of the remaining 2, we found that both had loose screws that were near to falling out. The Tram housing on our four Transport Pro monitors have been secured with a screw and locking nut until GE is notified and responds with an official modification.


Device:
Type: Pump, Intra-aortic Balloon, Air Transport
Manufacturer: Arrow International, Inc.
Brand: Autocat2
Model#: Autocat2

Problem:
This incident concerns equipment malfunction during a Survival Flight patient transport. The incident occurred at the bedside in the Cardiac/surgical ICU at an Out Side Hospital. The patient had an Intra-Aortic Balloon Pump (IABP) in place. The patient had been successfully transitioned from the unit's IABP to the transport IABP. It had been running normally for approximately 90 minutes when the display screen went blank on the transport IABP. Shortly after, a burning odor was noticed. The lower right part of the screen became warm to the touch and began to discolor. The screen was then unplugged. The IABP continued to pump. The patient was placed back on the home unit IABP. A second IABP was flown from our hospital. The patient was placed on the replacement transport IABP successfully, and the transport was completed to the hospital. At no time did the patient have a drop in blood pressure or cardiac output. There is no service bulletin from Arrow; they issued a Tech Tip "Display Head Locknut Improvement" document. I think this should be a corrective action.


GENERAL & PLASTIC SURGERY

Device:
Type: Cap, Surgical
Manufacturer: Medline
Brand: Pro Series
Lot #: 1005121063
Cat #: NON28233B

Problem:
Surgical technician noted that the surgical caps, "bouffant caps" were a much darker color than usual when the was box opened. The technician noted that the left side of her hairline was red "like a burn". She was sent to employee health for follow up.


Device:
Type: Endowrist Instrument Needle Driver
Manufacturer: Intuitive Surgical, Inc.
Brand: Mega Needle Driver For Davinci System
Model#: 420194
Lot #: VER-05 1301 071 943
Cat #: 420194
Other #: 8mm

Problem:
Operating staff report that while surgeon was utilizing an 8mm Mega Needle Driver in a robotic assisted surgery one of the cables broke. The cable evidently moves the tip of the device when handpiece is triggered (moved). You can visualize the cable sticking out the tip of the device. The device is evidently meant to have "10 lives". After each case the device is sent to our Sterile Processing Department and re-used until the 10 uses have expired. The device in question was on its 10th use. No injury to patient; surgeon confident no pieces of the cable entered the surgical site. Device sequestered and removed from field. New device of same type/model obtained and used to complete the case with no further issues.


Device:
Type: Stapler, Skin
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Proximate
Model#: PXR35
Lot #: H4375P
Cat #: PXR35

Problem:
Closing skin after a C-section and the stapler kept making a click noise and the staples would come out straight and not curve around in the skin. Seven total staplers opened before skin was closed.


Device:
Type: Surgical Drape
Manufacturer: Cardinal
Brand: Surgical Drape
Cat #: 3/4 sheet, split sheet

Problem:
Doctor was using the tps burr (6.5 ) After use it was put down on the drapes, and it melted a hole through the top 2 drapes. This happened again after using the burr. The drape was covered with sterile ioban. After the case the affected portion of the drape was removed and sent to biomed. The tps automatically sets the speed for the burr.

See device images:

image shows a hole on a surgical drape; hole is approximately a centimeter wide and resulted after a tps burr made contact with the surgical drape

close up image showing a hole on a surgical drape

image shows a hole on a surgical drape and a ruler to the right of the hole.  Ruler indicates the size of the hole is approximately a centimeter in size

 image shows a hole on a surgical drape and a ruler to the right of the hole.  Ruler indicates the size of the hole is approximately a centimeter in size


Device:
Type: Surgical, Razor
Manufacturer: Medline
Cat #: PMM# 9893 DYND70845
Other #: Handle/Head

Problem:
There are four written reports and several verbal reports that indicate when using clippers prior to procedures, abrasions, scratches, and nicks were found on the patient after use of the clipper. This product has been used at this facility for approximately three years. This issue just started to occur in the spring of this year according to my knowledge. There is no large turnover of staff.


Device 1:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc
Brand: Coated Vicryl
Model#: J555G
Lot #: DC5393
Cat #: J555G
Other #: Needle: 7.6mm, 1/4 circle, Spatula

Device 2:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc
Brand: Coated Vicryl
Model#: J555G
Lot #: CK6808
Cat #: J555G
Other #: Needle: 7.6mm, 1/4 circle, Spatula

Device 3:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc
Brand: Coated Vicryl
Model#: J555G
Lot #: CK6808
Cat #: J555G
Other #: Needle: 7.6mm, 1/4 circle, Spatula

Problem:
During an eye strabismus surgery a 6-0 Vicryl suture was used and began to fray in several areas along the suture.

A second procedure was scheduled same day with a new patient. The OR nurse obtained the same 6-0 Vicryl sutures but from a different lot than the first failure and the same fraying occurred. The physician did continue to use the frayed suture once started in both of these cases.

In a third case, same day, same procedure, the 6-0 Vicryl suture package was opened from sterile packaging for use. The physician noted at that time the suture was frayed. This suture was not used and retained.

All remaining boxes from both lots have been removed from OR stock to be returned to manufacturer.

Manufacturer response for Suture, Absorbable, Coated Vicryl, (per site reporter): Vendor representative contacted by Materials Management. All unopened boxes from both lots to be returned and replaced with new.


GENERAL HOSPITAL

Device:
Type: Catheter, PICC
Manufacturer: Cook Medical
Brand: Cook Medical
Model#: G50740
Lot #: 2663751
Cat #: G50740
Other #: UPICS 5.0 CT ABRM

Problem:
During insertion of PICC catheter, Physicians Assistant (PA) was withdrawing the guide wire and the distal tip broke off and was retained in the patient's arm.


Device:
Type: Catheter, PICC
Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.
Brand: L-cath PICC
Lot #: 384539

Problem:
PICC was life line to patient. The catheter was removed in its entirety without any dislodgement to the heart or pulmonary vasculature. The added radiation absorbed dose (RAD) exposure was twenty minutes. At twenty minutes physician and team had a small fragment dangling in the femoral vein out of reach surgically. The consequences of the piece embolizing to the heart or more dreadful to the pulmonary vasculate could be huge. The team was close to removing the fragment via IR and physician felt it was the best and safest procedure with more RADS. Indeed the decision paid off as the fragment was retrieved. Total RAD was twenty-two minutes. More info: L-Cath PICC essentially fell apart and required interventional radiology to remove the intra-abdominal intravascular portion of the catheter. Physician had to surgically remove fractured fragments from the leg veins. Patient's vein had created a fibrin sheath around the catheter causing it to be stuck within the vein.


Device:
Type: Catheter, PICC
Manufacturer: Bard Access System, Inc.
Model#: 5FR DL MB INT TRAY W/SHERLOCK & SAPIENS
Lot #: LOT REVA1234/REVB0941
Cat #: 1275108D
Other #: REF# 331968

Problem:
In the morning, the PICC Nurse was removing the guide wire from a newly placed PICC catheter. The PICC catheter bunched up and split during the removal. The catheter was immediately removed and pressure held. There was no harm to the patient.


Device:
Type: Catheter, PICC, Introducer
Manufacturer: Bard Access Systems
Brand: Microez Introducer
Model#: 0678935
Lot #: REVC0022
Cat #: 0678935

Problem:
RN attempted peripherally inserted central catheter (PICC) line in patient's left upper arm. Vein successfully cannulated using guided ultrasound and then guide wire was introduced. Micro-Introducer then was placed over guide wire without complications to secure location within vessel. Good blood return coming from outer open edge of the micro-introducer. Upon trying to pull inner cannula (dilator) out of the micro-introducer, the guide wire began to shred. Procedure immediately stopped and MD notified. Upper arm x-ray taken to visualize wire location and RN held guide wire securely until assessed by pediatric surgeon. Wire successfully removed by surgeon and pressure dressing placed over site.


Device:
Type: Catheter, Picc, Introducer
Manufacturer: Vygon
Brand: Nutriline -Catheter With Splitting Needle
Model#: ref 1252.30
Lot #: 042494

Lollipop Icon

Problem:
While RN inserting PICC line, the PICC line introducer's splitting needle broke at wings leaving needle on the catheter. RN unable to remove needle from catheter so line had to be pulled and infant re-stuck for line.


Device:
Type: Catheter, Umbilical Artery
Manufacturer: Covidien
Brand: Polyurethane Umbilical Vessel Catheter With Luer Lock Hub
Cat #: 8888 160333

Lollipop Icon

Problem:
After accessing umbilical artery catheter (UAC) with stop-cocks closed and all connections tight, blood was flowing back quickly from baby. When investigated, a split was found in UAC below hub. The UAC was clamped and MD notified. UAC was eventually removed. There was no apparent injury. Blood accessed by drawing labs via venipuncture or heel stick.


NEUROLOGY

Device:
Type: Holder, Head, Neurosurgical (Skull Clamp)
Manufacturer: CAREFUSION 2200, INC.
Brand: Spetzler

Problem:
Event involved skull head holder and base unit. Patient had cervical stenosis. Patient was scheduled for C5-6 laminectomy, left C5-6 and left C6-7 foraminotomies. During pre-operative safety check equipment found to be functioning properly. When positioning the patient the head holder malfunctioned and the case was aborted.


Device:
Type: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Manufacturer: Advanced Neuromodulation Systems Inc.
Brand: Eon Mini
Model#: 3788

Problem:
Patient had a successful implantation of ANS Neurostim Spinal Cord Stimulator (SCS) ~3 years ago. This SCS was noted to have a failure after 2 years of implantation. Patient returned to surgery recently for replacement of SCS generator.

Recall online available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94501


ORTHOPEDIC

Device:
Type: Bone Graft
Manufacturer: Medtronic
Brand: Infuse
Lot #: M111057AAD
Cat #: 7510200

Problem:
Sterility associated with BMP-2. Inflammatory reaction occurred that injured superior hypogastric plexus.



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Lollipop Icon
Special 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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