Highlighted Reports
MedSun: Newsletter #62, July 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 April 1 through April 30, 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.


ANESTHESIOLOGY

Device:
Type: Flowmeter
Manufacturer: Amvex Corporation
Brand: Dial Flowmeter
Model#: F10-2G0A3

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Problem:
ECMO [Extracorporeal membrane oxygenator] sweep flowmeter was adjusted from 6 L/m [liters per minute] to 7 L/m. The flowmeter does not have a 7 L/m setting. It has settings at 6 then 8 L/m. At the in between the area there was no oxygen flow. The patient became hypoxic. The MD was notified and the oxygen device was changed. During rounds, team wanted sweep to be turned from 6 to 7. At this time bedside RN notified ECMO and proceeded to increase sweep to 7. A few minutes later sats [saturations] began to drop significantly (lowest of 12%) as well as SVO2 [Saturated Venous Oxygen] (as low as 30%). ECMO charge immediately called to bedside as well as attending MD, RT [Respiratory Therapist] and charge RN. Attending at bedside with bedside RNs assessing patient and ECMO equipment. Oxygen from wall appeared to be working at times and at others not, so ECMO flow meter attached to oxygen tank and sweep increased on dial per MD. At this time, sats began to increase as well as SVO2 [Saturated Venous Oxygen]. At this time ECMO at bedside and explained that the ECMO sweep dial turns off when dial adjusted to 7 and needs to be changed to a different flow meter to increase sweep to 7. SICU staff unaware of this information. Patient vitals returned to his norm with no apparent complications noted at this time.


Device:
Type: Pulmonary Function Testing System
Manufacturer: CareFusion Viasys Healthcare
Brand: Vmax Encore
Model#: 229

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Problem:
Abrupt stopping of the treadmill occurred during Pediatric Exercise Testing. We were told by CareFusion Tech Support that CareFusion knew about this "glitch" prior to the install and training, but continued with the install and training with no prior notice to us. We were told by sales and service that the company would get back to us with an update as to the course of action CareFusion is taking to remediate this problem. Our new system has been shutdown since determining the nature of this glitch.


CARDIOVASCULAR


Device:
Type: Catheter, Intra-aortic Balloon
Manufacturer: Arrow International
Brand: Fiberoptix
Model#: IAB-05830-LWS
Lot #: KR1019018
Cat #: IAB-05830-LWS
Other #: 8 fr. 30cc

Problem:
This report is intended to document a series or trending of events rather than a specific event. Information on one catheter and patient was supplied in order to provide a sample serial and lot number for reference. There are two ongoing issues with the balloon catheter: first is that the fiber optic feature of the device frequently fails, in that the device (catheter) fails to be recognized by the console, and the physical connector for the fiber optic line falls apart. The blue slide connector which houses the tip of the fiber optic cable has literally fallen off of the catheter, so a connection to the fiber optic sensor cannot be made. The second is that the arterial line associated with the catheter, composes the secondary trigger for the balloon pump. When the fiber optics fails, the catheter clots off easily, requiring the operator to switch to the ECG leads as the only remaining trigger.

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Manufacturer response for Catheter, Intra-Aortic Balloon, FiberOptic: Multiple and on-going discussions with the local Arrow representative.
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Representative has been involved since the beginning with the concerns and has been meeting with staff and engaging them in training, education, answering questions as needed. The representative has and remains very involved in our efforts to sort out the problem.


Device:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: Arrow International, Inc
Brand: Arrow Central Venous Catheterization Kit
Cat #: CDC-45703-P1A

Problem:
A physician was inserting a central line. The left chest was prepped. The vein was accessed on first attempt but wire broke (and fully retrieved). The physician said he had no trouble with a rib or clavicle. It was a smooth entry. The dilator catheter was over the wire. When the catheter was in and the physician was pulling out the wire, it wouldn't budge. He tugged a little harder. The physician said it felt tighter than it should have been. There was more resistance than you would expect. He said the outside part came off and the wire came unraveled. The physician said he has inserted multiple lines and this has never happened before or since. The packaging was not saved. The physician told staff he wanted the company notified.


Device 1:
Type: System, Magnetic Navigation, Cardiac
Manufacturer: Stereotaxis
Brand: Niobe

Device 2:
Type: Computer, Diagnostic, Programmable, Cardiac
Manufacturer: Biosense Webster
Brand: Carto 3

Device 3:
Type: Generator, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Stockert

Device 4:
Type: Pacemaker, Implantable
Manufacturer: Medtronic Adapta
Brand: Adapta Dr
Model#: ADDR01

Problem:
The patient's dual chamber Medtronic pacemaker was set to demand pacing only mode (VVI) at rate of 40 beats per minute during a procedure using Stereotaxis Magnetic Navigation System (MNS). When the MNS system was moved into navigate position, the pacemaker went into "magnet mode" (VOO) asynchronous pacing at 85 beats per minute. To prevent complications from inappropriate pacing, the output was decreased from 2.0 V to 0.5 V (to intentionally lose capture and prevent pacing). During first application of radio frequency (RF) ablation, ECG morphology changed to what appeared to be paced beats at about 130 beats per minute at higher output. When RF ablation was terminated, the device would stop pacing and the patient's underlying tachycardia at 145 beats per minute was seen on ECG. The phenomenon was repeatedly reproduced with RF application. Grounding pad location was moved from left flank to left thigh, which intermittently resolved the issue. Medtronic rep on site was consulted, and Medtronic engineer called by telephone, but no clear cause was identified. Medtronic rep arrived in room to perform device interrogation once the MNS system was moved to stowed position. Error message on device indicated it had gone to Reset which returned device to the default factory settings of DDD (dual-chamber pacing) 60-130, output of 3.5 V. Patient's low threshold (~1.0V) allowed max tracking pacing at 130 beats per minute to capture, and her underlying tachycardia did not require pacing when off RF. Had the patient been pacemaker dependent with a threshold above 3.5V, no pacing or lack-of-capture and asystole would have occurred. Conversely, had the patient had heart failure or poor cardiac function, the rapid ventricular pacing at 130 beats per minute may have caused hemodynamic collapse. Therefore it was felt this should be reported to MedSun/HeartNet as a significant event with potential to cause harm. The pacemaker is still implanted and the patient had a good outcome.

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Manufacturer response for Carto 3 RMT electroanatomic mapping system, EO Medelctrophysiology recording system, Xper hemodynamic recording system, Zoll M Series defibrillator, Siemens Artis Zee fluoro system, Stereotaxis/Niobe Remote Magnetic Navigation system., Medtronic Dual Chamber Pacemaker (per site reporter)
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Medtronic rep here during procedure. Called technology department.


Device:
Type: System, Endovascular Graft, Aortic Aneurysm Treatment
Manufacturer: Cook
Brand: Zenith Aortic Stent Graft

Problem:
Patient presents with aortic stent graft infection. Infection was noted to be at 1 to 1 1/2 cm at the top of the bare metal stent, not near the fabric. This is extremely unusual per doctor.


GENERAL & PLASTIC SURGERY

Device:
Type: Ampule, Tissue Adhesive
Manufacturer: Ethicon
Brand: Dermabond
Lot #: CKR017

Problem:
According to directions, while crushing ampule the product splintered and broke into sharp pointed pieces. The doctor received a laceration to right index finger.


Device:
Type: Clip Applier
Manufacturer: Teleflex Medical
Brand: Hem-o-lok
Model#: 544965
Cat #: 544965

Problem:
Surgeon was using the Hem-o-lok during a cholecystectomy. He used the device to apply a self-locking plastic clip to the cystic duct. While attempting to apply a clip with the Hem-o-lok Endo applier the clips would not apply or clip. Another Hem-o-lok Endo applier was used successfully to apply the clips. There was no adverse result to the patient. When the malfunctioning applier was examined the jaws appear to be slightly out of alignment. This was not apparent without closely looking at the device. After the case, the surgeon later devised a small tool to check the alignment of the appliers before using in other cases.


Device:
Type: Clip Applier
Manufacturer: Covidien
Brand: Premium Surgiclip
Model#: S-9.0
Lot #: P1B0186
Cat #: 134046

Problem:
When going to apply a clip on the blood vessel two or more clips pushed out leaving loose metal clips in the wound, which had to be picked out. Looking back at our hospital event system this is one of six such events that have happened over the last eight months. Because of this number it was decided that these events needed to be reported. Other events included: failed to place clips properly, clip malfunction, clips did not bind and cut the colon, clip applier failed to load a clip while jaws came forward and sliced the patient's vein. Clips did not close properly. The clip applier sliced the vein when trying to apply a clip and then spit out an extra clip into the wound. All events are related to the same product number.

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Manufacturer response for Single Use Automatic Clip Applier, Premium Surgiclip
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We have not had a response back from the manufacturer to date.


Device 1:
Type: Clip Applier
Manufacturer: Covidien
Brand: Auto Suture
Model#: S-9.0
Cat #: 134046

Device 2:
Type: Clip Applier
Manufacturer: Covidien
Brand: Auto Suture
Model#: M-9.75
Cat #: 134051

Problem:
Surgeon reports that device clip delivers an inaccurate clip and has to be removed and/or replaced. This event has been reported on three occasions. In this case, the mammary artery was cut.


Device:
Type: Clip Applier
Manufacturer: Ethicon-Endo Surgery
Brand: Ligamax
Model#: EL5ML
Lot #: G4UF5P

Problem:
While performing laparoscopic cholecystectomy, clip applier was extremely hard to fire. Another unit was obtained with same problem. Another unit was then opened and still had some difficulties, notably the "handle was hard to fire, sticky".


Device:
Type: Dispersive Electrode
Manufacturer: ConMed Corporation
Brand: Macrolyte
Lot #: 1101035
Cat #: 450-2300
Other #: P/N 6859-37

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Problem:
Out of three types and sizes of cautery pads, two had weight limit guidelines and one did not. This is the pad needed for our small patient. Rep [representative] was called and got answering machine. Company was called three times by RN until she was able to contact the vice pres [president] of marketing. Weight class was verified by Vice President and pad was proceeded to be used and applied by doctor. This baby girl was under general anesthesia for 1 hr 4 min while the company was trying to be reached to get the needed information.

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Manufacturer response for Dispersive Electrode, MacroLyte
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The infant was under anesthesia for 1 hr 4 min while this company was trying to be contacted. The company rep did not answer the phone either.


Device:
Type: Stapler, Skin, Absorbable
Manufacturer: Incisive Surgical, Inc.
Brand: Insorb
Model#: 2030

Problem:
Patient with no significant medical history fell, sustaining a left tibial plateau fracture with extension into the tibial shaft. The patient underwent open reduction, internal fixation of her left tibial plateau fracture with a buttress plate, and open reduction and internal fixation of the tibial shaft with periarticular plate; the wound was closed with absorbable skin staples. The patient developed multiple skin blisters, non-viable tissue and a large hematoma requiring removal of skin staples and evacuation of the hematoma with muscle flap and skin graft. Due to non-healing, patient required removal of hardware and above knee amputation.


Device:
Type: Stapler, Skin, Absorbable
Manufacturer: Incisive Surgical, Inc.
Brand: Insorb
Model#: 2030

Problem:
The patient underwent a right triathlon total knee arthroplasty with tobramycin-impregnated methyl methacrylate with a #4 right femur, #4 primary tibia with a 13 mm CS x3 insert, #32 mm symmetric patella with Stryker navigation. The skin was closed with absorbable staples. The patient was readmitted with an infected hematoma of there knee, underwent an excision of non-viable tissue, removal of multiple foreign bodies, evacuation of the hematoma, and a split thickness skin graft. The foreign bodies were discarded.


NEUROLOGY

Device:
Type: Motor, Drill
Manufacturer: The Anspach Effort, Inc.
Brand: Emax Qd8

Problem:
The surgeon was doing a translabyrinthine approach to resect a left vestibular schwannoma. An Anspach drill Emax QD8 head had been used for approximately 1 hour when the sleeve shot forward off the device like a missile. The surgeon had quick reflexes and pulled back preventing the patient from being harmed. The patient would have been seriously injured otherwise.


OPHTHALMIC

Device:
Type: Phaco Tubing Pack.
Manufacturer: AMO Abbott Medical Optics
Brand: Whitestar Signature Fusion Pack
Lot #: CHO1228 and CJO0095
Cat #: OPO70
Other #: AMO WhiteStar Signature Phacoemulsification machine

Problem:
Nurse was setting up and priming set; observed that tubing was not connected correctly to cassette. Examination revealed that small rigid plastic connection port was broken. Nurse requested another set which was connected properly and which primed properly. Case proceeded. Slight delay in set-up time resulted. No adverse event. Note that this event happened twice on the same day - i.e. for two separate IOL cases.

OR reports that this is a low frequency but recurring event. They estimate that this is happening about 6 times per 1000 IOL cases. Unable to determine if this is a defect in manufacturing or if this suggests a need for better in-service of staff. Digital photographs of defective device have been sent to MedSun.

See device image:
 Close up photograph of phaco tubing that was not connecting to cassette.  Image shows broken rigid plastic connector port that was broken, the reason why it was not connecting properly.



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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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