Highlighted Reports
MedSun: Newsletter #46, March 2010

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 December 1 through December 31 2009. 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: Monitor, Central Station
Manufacturer: Philips Medical Systems
Brand: Intellivue Information Center
Model #: M3155
Other #: Software K.00.27


Problem:

A non Philips keyboard was installed. The substitute keyboard had a mute function on it and the Philips keyboard does not. The mute button was pushed by accident on the substitute keyboard and as a result the alarms were heard from bedside monitor and not at the central station.

Biomedical was called and corrected problem by replacing the keyboard with a Philips keyboard.


Device:

Type: System, Thermal Regulating
Manufacturer: Arizant Inc.
Brand: Bair Hugger
Other #: 83125

Problem:

Soon after turning on Bair Hugger, an explosion and flame occurred from unit. Bair hugger immediately removed. Patient assessed. No harm to patient. Problem was found to be the power cord/plug; wires had become dislodged.

Comment from FDA: Recall online available on manufacturer’s website: http://www.arizant.com/pdf/us/603194.pdf


Device:

Type: Fibrillator, Ac
Manufacturer: Peter Schiff Enterprise
Brand: Cardiac Fibrillator
Model #: 310C

Problem:

The Fibrillator pad was placed directly on the patient's heart by the MD. The pad was properly connected to the Fibrillator device by the RN, and then turned to full power at the MD's request. No power was delivered to the pad, although, the output test light came on. We changed out the pad and tried the device again, but there was still no power delivered to the pad. The connections were checked with no response to the change. We were not able to fibrillate the patient using the Fibrillator. We had to cool to fibrillate. Biomed verified the problem with the Fibrillator.


Device:

Type: Monitor, Central, Telemetry
Manufacturer: Phillips Medical Systems
Brand: Intellivue
Model #: M3150B

Problem:

A patient with multiple medical problems had a tracheotomy tube and had a telemetry pulse oximeter monitor which was connected to the central monitor in the nursing station. The patient was found unresponsive with the trach out. Investigation revealed that the staff does not recall hearing the central monitor desaturation alarm. The alarm has settings of 1-10 and was found to be set at "1". Engineering staff can set a minimal alarm level that staff can't go below. As a result, the central monitor minimum alarm volume setting was increased for the involved unit. In addition the central monitor minimum alarm volume setting for each unit in the hospital was assessed and confirmed to be at an appropriate level based on each unit's configuration.


Device:

Type: Electrode, Defibrillator, Medi-trace
Manufacturer: Covidien Kendall
Brand: Medi-trace Cadence Rts
Model #: 22770R
Lot #: 926114

Problem:

Zoll patches were labeled the same, i.e. both pads in the package were identified as being left side pads. This was discovered before the patient was prepped and draped. This was an out-of-the-box failure. There was no harm to the patient.


CLINICAL CHEMISTRY

Device:

Type: Test Strips
Manufacturer: Lifescan Inc.
Brand: Surestep Pro
Lot #: 2947225009
Other #: CTL Code: 0311POUNK

Problem:

Nurse used chemstrips to ascertain infant's sugar level. The RN thought the reading was low and not what had been infant's previously recorded levels. She noticed on the back side of the chemstrip that what should have been a consistent blue was "blotchy" and an "uneven" color. Did a second chemstrip with same result and again there was an uneven blotchy color. Secured chemstrip from different lot and result was more consistent with previous readings.


ANESTHESIOLOGY

Device 1:

Type: Ventilator
Manufacturer: Maquet, Inc.
Brand: Servo IVentilator
Model #: Servo i

Device 2:

Type: Ventilator
Manufacturer: Maquet, Inc.
Brand: Servo IVentilator
Model #: Servo i

Problem:

Transported a low weight infant to radiology for MRI. Ventilators in MRI room did not work. An error message kept occurring.

Tech Error 27 message was generated after ventilator was taken over for use in MRI. Ped's
Servo-i had generated this error code as well. Both vents were in the MRI environment when turned on and error code generated. Both vents were outside of the Safety Zone. Unable to duplicate this error code when the vent was moved to prep area. Tech support was contacted and notified of this error code and service order generated.

This is 3rd time this error code has generated on this vent. Board 1772 was replaced due to this alarm. MRI management is not comfortable with this vent going back into use until representation from mfr is met with and this concern is fixed. Maquet rep notified to setup meeting with MRI management group.


RADIOLOGY

Device:

Type: Ultrasound Probe Cover, Surgical/intraoperative
Manufacturer: Microtek Medical, Inc
Brand: Ultracover
Model #: PC4515
Lot #: D90631
Other #: Large T-shaped latex free probe cover w/gel

Problem:

Ultrasound was being used for intraoperative guidance for an open liver resection which required sterile draping of a clean ultrasound probe which was then placed inside the body cavity on two separate occasions during the operation. Between each insertion of the probe, it remained sterile and on the sterile field. When the surgeon was finished with ultrasound guidance the radiologist undraped the probe and noticed blood mixed with the gel inside the probe cover which indicated a defect in the probe cover, as no material should pass through the cover itself to maintain sterile technique. The probe cover was checked for a tear - it had a gap between the rubber and plastic portions of the probe cover that should normally be sealed closed to prevent material from crossing the barrier of the probe cover to maintain a sterile field. Other probe covers were also determined to not seal effectively enough to prevent them from detaching/allowing contamination.

We have asked that the stock be replaced, as all probe covers seem ineffective.


Device:

Type: Workstation, Angiographic Imaging
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Leonardo
Other #: Rotational angiography with 3 D image

Problem:

When processing 3-D reconstructions of left atrium for electrophysiology studies and ablation on the Leonardo Workstation the resolution has been unacceptable to our clinicians. Siemens has recently informed us that the software on this 10 month old workstation is an earlier, lower resolution, version, which captures images every 1.5 degrees. A newer version of the Workstation software apparently offers the higher resolution, which captures images every 0.8 degrees, which would be required to process these images adequately on our system. The issue was discussed with staff at the Siemens training center in North Carolina. According to them, seven months after the install, the low resolution software is no longer available on small detectors like ours because it does not allow for adequate image quality.

As this is an adjunctive imaging tool it is not essential to performing the case. Atrial Fibrillation ablations are usually done without this technology in many centers that have not purchased the system. The goal is to superimpose a three-dimensional shell onto the x-ray screen for better catheter navigation and to guide transeptal puncture, with the hopes of reducing fluoroscopy time and improving patient safety. Atrial Fib ablations can continue to be safely performed without this technology; we are just not getting the added safety benefit that was the intention of the purchase. Instead, by trying to use the technology as intended we are exposing the patient to risk with pulmonary artery catheterization, contrast injection, additional anesthesia time and additional radiation exposure we would not otherwise do in an AF ablation, with often unusable results. In these instances there is no benefit to offset this accumulation of small risks.


NEUROLOGY

Device 1:

Type: Motor, Drill, Pneumatic
Manufacturer: Medtronic
Brand: Midas Rex

Device 2:

Type: Drills, Burrs, Trephines &Accessories (Simple, Powered)
Manufacturer: Medtronic
Brand: Midas Rex Legend
Model #: F2-B1
Lot #: 0001122106
Cat #: F2/8TA23

Problem:

The MD was using the dissecting router when the drill bit drove straight through the foot plate and into the dura. It is unknown which part of the Midas Rex device malfunctioned. There is the motor, the drill bit, and the nose cone attachment with foot plate.

Comment from FDA: See recall online available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87002


GENERAL HOSPITAL

Device:

Type: Iv Insertion
Manufacturer: BD Medical
Brand: Insyte Autoguard Shielded Iv Catheter
Lot #: 8276402
Cat #: 381444

Problem:

Nurse used a BD Medical Insyte Autoguard Shielded IV Catheter to start an IV. Device entered blood vessel smoothly according to procedure. Nurse pressed release button to retract the needle and expected the catheter to remain in the patient with the Luer adapter (hub) on the skin surface. However, when she pressed the button, the Luer adapter fell to the bed and then the floor. Not seeing where the catheter and metal retainer went, she assumed it entered the patient's blood stream, applied pressure to prevent its movement and requested assistance. Another nurse and two doctors came to assist. A portable C-arm was used to fluoro the hand and forearm, but revealed no catheter. One of the doctors examined the Autoguard device and noticed that the catheter and metal retainer had retracted with the needle into the handle of the Autoguard device. The patient was not at risk, but did require intervention. The patient was not charged extra for the intervention.

Manufacturer response (as per reporter) for IV insertion, Insyte Autoguard Shielded IV Catheter

Very helpful, cooperative and sincerely concerned. Complaint Analyst / Regulatory Compliance, took information via phone and e-mail; also arranged for the return of the device for analysis. She stated that since interventions were used, they would also be filing a report with the FDA.


Device:

Type: Tubing, Iv
Manufacturer: B. Braun Medical, Inc.
Model #: US3130
Cat #: US3130

Problem:

Nurse tried to place tubing into the pump chamber. The tubing between the cassette and the key pin or clamp contained slack (too long), and should have been tight in the chamber. The additional tubing length would not allow the front cover to close or the pump to operate.


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