Highlighted Reports
MedSun: Newsletter #37, June 2009

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 March 1 through March 31. 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: Stent, Superficial Femoral Artery, Self-expanding
Manufacturer: EV3 Inc.
Brand: Protege Everflex
Lot #: 4960631
Cat #: VBC061502

Problem:

The stent did not deploy fully open. It shortened and became very distorted. The stent shortened to half of the specified length. The patient required additional ballooning techniques with multiple balloons and placement of two viabahn covered stents. The end result was an open SFA.

FDA comment: Not approved for peripheral use in the United States.


Device: Catheter, Balloon, Dilatation
Manufacturer: Boston Scientific Corp.
Brand: Ultra-thin Diamond Balloon Dilatation Catheter
Model #: M001164830
Lot #: 9228437
Cat #: 16-483

Problem:

Poorly functioning arteriovenous fistula. Balloon rupture during PTA of in-stent re-stenosis. All pieces retrieved. Per Director of the unit, rupture may have been prevented if inflator was utilized.


Device: Defibrillator, External
Manufacturer: Medtronic Emergency Response Systems
Brand: Lifepak 20
Model #: LP-20
Problem:

During surgical procedure, a synchronized cardioversion attempt was made with the device in manual mode. Upon pressing the sync button and observing proper operation, the defibrillator was charged to 360J. After a shorter than expected time, the unit appeared to be ready for discharge. Upon discharge, the unit gave either a "connect electrodes" or a "remove test plug" message. We are not sure which. The unit gave a service light and continued to give the message. Another defibrillator had to be obtained to provide therapy needed by the patient. Pads checked and compatible with defibrillator.

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Manufacturer response for Defibrillator, Lifepak 20
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With Risk Mgmt. approval, call was placed for field service support since the unit is under warranty. The unit gave a 9021 error code at the time of the failure. Their service documentation indicates that newest software should be installed as the corrective action for this. Service rep installed latest software.

Installed Material:
Qty = 1 3203332-019 KIT-UPGRADE,SW,MODULE 070,LP20,ENGLISH

Upon further consideration, the rep took the unit with him to deliver to Regulatory Affairs with the company. He updated software on all other units in our OR areas. I am currently trying to make contact with the representative in Regulatory Affairs to try to get this software installed on the rest of our units. We have 79 of them within our facilities.


Device: Catheter, Ablation
Manufacturer: Biosense Webster
Brand: Navistar Thermocool
Lot #: 13451381
Cat #: N175TCDH
Other #: Ref #34H37M

Problem:

Patient was to receive an RF ablation for atrial fibrillation. The RSPV was accessed without difficulty or resistance. However, the ablation catheter could not be withdrawn beyond the vein. Despite manipulation of the catheter with and without the aid of the trans-septal sheath, the tip of the catheter was affixed to the pulmonary vein. Using Intracardiac Echo and fluoroscopy, the position of the catheter was verified to be in the PV. There was no evidence of pericardial effusion at that time. Despite at least moderate traction, the tip could not be freed. Patient ultimately had to be transferred to surgery so that a sternotomy could be performed. The ablation catheter was then able to be removed and a full left atrial Maze procedure was done. Post-op course uneventful and patient was discharged home on post-op day 3.


GENERAL HOSPITAL

Device: Hospital Bed
Manufacturer: Stryker Medical
Brand: Secure Ii Med/surg Bed
Model #: Secure 2, 3002EX

Problem:

Brakes were activated, but bed rolled under moderate pressure.

FDA comment: FDA has received other reports on this issue


Device: Infusion Pump
Manufacturer: Baxter Healthcare Corporation
Brand: Flo-gard
Model #: 6301

Problem:

A 5 ml/hr insulin drip was ordered. The medication and the pump settings were verified by two other RNs. The pump was set to infuse at 5 ml/hr, and the total volume to be infused was 20 ml. After 1 hour the pump began alerting "air". The pump had infused the total dose in less than one hour. The patient did not have any adverse effects other than an increased stay in ER.

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Manufacturer response for infusion pump
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Sent in the pump and spoke to Baxter via phone. No response until after they receive pump and test it.


Device: Sponge Applicator, 26ml Applicator
Manufacturer: Cardinal Health Skin Prep
Brand: Chloraprep with Tint
Model #: 260815
Problem:

The left neck was prepped with tinted chloraprep. Area draped. After working on other areas around the face, the left neck was undraped (approximately 35 minutes after prep). A flash fire occurred when the ESU was ignited. Superficial partial thickness burns occurred to the posterior neck, ears and upper back.

Additional information obtained from the site:
? Product # 260815, 26ml applicator
? The patient experienced first and second degree burns.
? Valleylab Force FX-C, F2C 21244A


Device: Stretcher, Patient, Hospital
Manufacturer: Styker Medical
Brand: Stryker Stretcher
Model #: 0735
Problem:

Transferring patient from stretcher to procedure table, found brakes not working. Healthcare professional had to put their body against the stretcher to keep it from moving away from procedure table during patient transfer.

Recall available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=65428

Device: Iv Tubing
Manufacturer: Baxter Healthcare Corporation
Brand: Continu-flo Solution Set
Model #: 2C6537s
Lot #: S08125091R (probable)

Problem:

The sister of a patient ran out of the room to find a nurse to call for help. She yelled, "patient is bleeding.” Two RN's entered the room to find a significant amount of blood on the floor. Tubing was connected to a central line (broviac), and the connection was intact. However, there was fluid and blood dripping partway out of the primary IV tubing. A hole in the tubing was observed. The patient was stable. The patient’s hemoglobin level was 12 on admission and 10.9 the following day. The break to the sterile IV system puts this oncology patient at greater risk for a blood stream infection. There was a potential for greater blood loss had there not been someone at the bedside.

Device: Infusion Pump
Manufacturer: Hospira Global Medical Affairs
Brand: Symbiq
Model #: 1602604
Cat #: 1602604

Problem:

The IV pump was attached to the IV pole. The nurse stepped out of the room and heard a noise. The nurse returned to find the IV pump on the floor with the pole clamp still attached to the IV pole.

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Manufacturer response for Infusion Pump, Symbiq
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The manufacturer requested the pump be sent in for evaluation.


ANESTHESIOLOGY

Device 1: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 2: Anesthesia Machine
Manufacturer: GE HEALTHCARE
Brand: Aisys Carestation
Model #: S5AISYS

Device 3: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 4: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 5: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 6: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 7: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Problem:

During a scheduled Preventive Maintenance inspection, it was noticed that there was rust on the Rod of the Bag/Vent Switch assembly. The assembly was replaced with a new part. The suspected part was sequestered.

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Manufacturer response for ANESTHESIA MACHINE, ANESTHESIA MACHINE
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GE acknowledges that there is a problem, and are in the process of sending us an official letter, after their analysis and investigation is complete. The presence of Chloride in their manufacturing process, either during machining or cutting is contaminating the parts causing them to rust. They initially were using stainless steel grade 303 and switched to SS 313.


Device: Carbon Dioxide Absorbent
Manufacturer: Armstrong Medical
Brand: Amsorb Plus
Lot #: 220908F21
Problem:

This report involves the Amsorb CO2 filter on two of our anesthesia machines. The part that monitors the CO2 levels indicated that the inspired CO2 was increasing during a surgery. Biomed discovered after investigating that the problem was the Ambsorb container. (This product turns from white to violet when used, but in this case the product was still white.) Biomed looked at the canisters on all the machines and found one other failure where the device was not working as intended. The Biomed Tech noted that the two malfunctioning canisters had the same lot number. All products with that lot number at our facility were pulled off the shelf. The company has been contacted and they will be receiving the malfunctioning canisters for investigation.

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Manufacturer response for Carbon Dioxide absorbent, Amsorb Plus
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They will be testing the device

Device 1: Ventilator
Manufacturer: Newport Medical Instruments
Brand: E-500
Model #: E-500

Device 2: Nurse Call System
Manufacturer: Simplex Grinnell
Brand: Ez-care

Problem:

When the ventilator triggers an alarm it also triggers the nurse call system (Simplex Grinnell EZ-Care), the ventilator resets itself and so should the nurse call, but in some instances the vent nurse call port gets stuck or locks and keeps sending a signal to the nurse call system even if the vent is not alarming. We have to bag patient and reset power to vent to clear. Sometimes it does not work so we have to remove vent and install another vent.

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Manufacturer response for Ventilator
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We have complained several times over the past year, we have changed cables as they requested. They have been unable to find out the cause.


RADIOLOGY

Device: Computed Radiography Plate Reader
Manufacturer: Fujifilm Medical System, USA, Inc.
Brand: Fuji Fcr Xg5000
Model #: FCR XG5000
Cat #: CR IR 362

Problem:

While tech was developing an X-ray image in the Fuji CR reader, he noticed prior to sending to PACS, that images were incorrect. They "jumped into another patient's jacket". A service call was placed and Fuji service engineer came in. Logs were sent to Japan for review.

A similar event occurred approximately a year ago. The hospital believes that this problem may be triggered when a jam of a CR cassette occurs, and the CR reader is re-booted to clear the jam. Under these circumstances it appears that the CR image may be stored in the proper (new) patient's folder, as well as in the previous patient's folder (bearing the accession number of the new patient).

Fuji identified the cause of the issue and has installed a software upgrade Version 2.5 in the CR reader, which they have stated will prevent a repeat occurrence of this problem. The hospital has 13 of these CR readers and is in the process of having the upgrade installed in the other readers.


GENERAL & PLASTIC SURGERY

Device: Kit, Iv Site Prep
Manufacturer: Churchill Medical Systems, Inc.
Brand: Churchill Medical System
Model #: AMS-796CP
Lot #: 810124

Problem:

During an IV start for surgery the ChloraPrep Frepp sponge was activated and glass fragments were in the sponge leading to a superficial cut on the patient's arm.

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Manufacturer response for IV start kit, Churchill Medical System
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will evaulate the product


Device: Breast Biopsy Marker
Manufacturer: SenoRx, Inc.
Brand: Gel Mark Ultra
Lot #: 08H0725
Cat #: MK2011

Problem:

A breast biopsy marker was utilized during an uneventful stereotactic breast biopsy. A followup X-ray of the breast displayed both the marker as well as unknown metallic objects in proximity to the marker that were not intended to be left in the biopsy location.

The radiologist believes that the biopsy marker insertion tool left the unidentified metallic pieces behind. This belief is supported by the fact that an unopened biopsy insertion tool from the same lot was X-rayed and found to have a similar metallic object floating separate from the clip.

See images of fragment clip in breast tissue and the fragment clip in unopened package, respectively:

Clip with fragment in unopened package

Clip in breast tissue

Device: Wound Therapy System
Manufacturer: Kinetic Concepts, Inc.
Brand: Wound VAC
Model #: 60090

Problem:

Pump alarming "canister not engaged." However, the canister was never moved, nor was it touched in anyway since the patient arrived back from OR. Several attempts were made to take out and re-place the canister without success in fixing the alarm, also an electrical cord was found and cleaned and engaged to wound VAC without success. Several attempts at turning wound VAC entirely off then on again also did not fix the alarm. Another Wound VAC was secured and this wound VAC was replaced.

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Manufacturer response for Wound VAC, Wound VAC
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Wound VACs are rental devices from KCI. KCI maintains wound VACs.


Device: Kit, Laryngotracheal, Anesthesia
Manufacturer: Hospira
Brand: Lta 360 Kit
Model #: NDC# 0409-4698-01
Lot #: 63-295-R1
Cat #: 4698-01
Problem:

During vocal cord injection Laryngotracheal Anesthesia (LTA) glass vial broke [kit contains lidocaine].

Looked to be intact upon removal from package and was primed without problem.

Device 1: ESU, Generator
Manufacturer: Gyrus ACMI
Brand: Gyrus Generator
Model #: G400
Other #: ID # 56T-1993

Device 2: Electrode, ESU, Spatula
Manufacturer: Gyrus ACMI
Brand: Pks Plasma Spatula with Cord
Model #: 952005PK
Lot #: 71069KA or 67281JAJ
Cat #: 952005PK

Problem:

The patient had a laparoscopic hysterectomy. She returned 5 days later with complaint of pain, lleus and ureter obstruction. The patient returned to the OR and they found thermal injury to the bladder and left ureter. They also found thermal injury to the anterior surface of the rectum and the cul-de-sac. These were repaired and the patient had a stent placed and a suprapubic cystostomy tube. The physician felt the thermal spread was caused by the plasma spatula. The device was not saved because we were not aware of the problem till the patient came back in. I have included the 2 lot numbers of the spatulas that we have in the OR.

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Manufacturer response for Spatula, PKS Plasma Spatula with Cord
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Have not heard from them yet.

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Manufacturer response for Generator, Gyrus Generator
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Have not heard from them yet.


ORTHOPEDIC

Device: Implant, Total Artificial Hip, Femoral Head
Manufacturer: Stryker Orthopaedics
Brand: Lfit V40
Lot #: 28759003
Other #: REF # 6260-9-132

Problem:

Patient was in surgery for a hip replacement. The implant was mislabled as a 32mm but was actually a 26mm. The mislabeling was noticed prior to implantation. No harm to patient.

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Manufacturer response for Femoral Head, LFIT V40 Femoral Head
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The mfg's rep took the mislabled product and substituted with correct size.


GASTROENTEROLOGY & UROLOGY

Device 1: Capsule, Esophageal, Ph
Manufacturer: Medtronic Gastroenterology/Urology
Brand: Bravo Ph Capsule
Lot #: Q255009

Device 2: Catheter, Esophageal Ph
Manufacturer: Medtronic Gastroenterology/Urology
Brand: Bravo
Model #: 9012B1011
Lot #: Q255194
Other #: ID 7428

Problem:

The endoscope was placed at the top of the esophagus to view placement following the Bravo Ph capsule deployment at 31 cm. The suction used for the procedure was appropriate. The device did not completely attach to the inside of the esophagus and slipped down into the stomach. The endoscope showed a small amount of heme and a small lesion on the tissue where the clip attachment was attempted. The patient was transported to the post procedural area without injury.

Device: Introducer Kit
Manufacturer: Kimberly-Clark Corporation
Brand: Mic-key J/tj-16 Introducer Kit
Other #: 98437

Problem:

The introducer kit comes with a set of dilators (progressing from small to large) that are situated on one introducer that is approximately 12 inches long. Each dilator slides down the introducer through an incision made by the provider. There are four such dilators that are slid down in sequence to enlarge the incision. In this event, the first (smallest) dilator came off the end of the introducer into the patient's stomach during J-tube placement. The J-tube was placed inadvertently, and unknowingly, over this dilator. When the provider cut the tack/sutures to allow the stomach to return to its normal position, the J-tube was able to "pop" out of the hole made in the stomach. As a result, the J-tube communicated with the peri-gastric abdomen rather than the stomach. Tube feeds were started which emptied into the patient's abdomen. The patient was subsequently taken to the OR for washout where the unintentionally retained object was discovered. The dilator was able to slip off the end of the introducer (not designed to do so), and into the stomach unnoticed. Further, the dilator is not radiopaque so it cannot be detected on radiograph post procedure, or fluoroscopically. This was an isolated event. The reporter states that this is a new product, as within the last 12 months. It is believed that the device failed.

Dilator within Introducer Kit

Device: Feeding Enteral Tube W/stylet
Manufacturer: VIASYS Healthcare MedSystems
Brand: Feeding Enteral Tube W/stylet
Lot #: 34947
Cat #: 20-9225

Problem:

The infant was witnessed dislodging her nasogastric tube. A new tube was obtained and placed without difficulty in the opposite nares. The tube feeding was hung. This RN had checked on the patient several times over the following forty minutes, and the feed appeared to be infusing without incident. The feeding was noted to be done, but the patient was noted to be fussy, as if still hungry. When disconnecting the feed, the patient's bed was noted to be saturated with feed. The nasogastric tube was noted to be in place and all the connections were intact, but when this RN took a flush syringe and flushed the tube there was leakage noted at the connection point between the nasogastric and the clear y-connector. This is where the feed port and med port are attached.


HEMATOLOGY

Device 1: Analyzer, Blood Coagulation
Manufacturer: International Technidyne Corporation
Brand: Hemochron Jr. Signature +

Device 2: Analyzer, Blood Coagulation
Manufacturer: International Technidyne Corporation
Brand: Hmeochron Jr. Signature +

Problem:

Cath Lab manager reports concerns with either Hemochron Jr./Signature + machines or possibly the Cuvettes which were being utilized. At time in question, Cuvette ACT+ were being used. We are now using ACT-LR. Below is a summary of what happened, but we cannot definitively say there was a "malfunction". It was reported that while using the Cuvette ACT+, the times were lower with the amount of heparin given in some procedures. Our cath lab compared results using one blood sample between two Hemachron machines and a different mfr's machine. In one particular instance, the sample results were: The different mfr's machine read 219, Hemochron (both machines) read 171. These results were run simultaneously, side by side. The request had come from the physician when results from the same three machines, 50 minutes earlier showed the result from the different mfr's machine as 409. One of the Hemochron machines showed a result as 171 and the other Hemochron machine was not recorded. To summarize, when the cath lab used the ACT+ the times seemed to be low. We did not change our QA process and the numbers showed we were within ranges for the tests. We have since gone back to the ACT-LR and our physicians now have the confidence to believe the results.


Device: Analyzer, Hematology
Manufacturer: SYSMEX AMERICA, INC.
Model #: 2100

Problem:

The machine had a temperature error. The temperature was reset by turning the machine off and on. Ultimately, the entire red cell block was replaced by SYSMEX. Erroneous results were reported on several patients. Only one is listed in this report since it involved the same piece of equipment. No patient harm has come from this incident.


Device: Analyzer, Chemistry
Manufacturer: Siemens Healthcare Diagnostics
Brand: Advia Centaur Xp

Problem:

It was determined by the Siemen's engineer that the problem with the Centaur was a defective water valve. A piece of tubing came loose, and was flooding the bottom of the analyzer. Despite the condition, the machine flagged red and yellow, but continued to function albeit incorrectly. An engineer from Siemens was available and made the necessary repairs to the unit. It was back on line later that day.


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