Highlighted Reports
MedSun: Newsletter #61, June 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 March 1 through March 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.

ANESTHESIOLOGY

Device:
Type: Emg Endotracheal Tube
Manufacturer: Medtronic Xomed Inc
Brand: Nim Contact
Lot #: 71258000
Cat #: 8229506

Problem:
NIM machine was reading too much feedback for the stim one cord. We could not get feedback fixed. Switched to different NIM Endotracheal tube and feedback went away. The blue wire on the NIM Endotracheal tube didn't give feedback to the NIM Machine. They had to remove the tube and re-trach the patient with a new tube. The new one worked fine.

Device:
Type: Endotracheal Tube
Manufacturer: Covidien Nellcor Mallinckrodt
Brand: Reinforced Tracheal Tube
Model#: Cuffed
Lot #: 2001-03 4934
Cat #: 86553

Problem:
Intubated ICU patient, s/p [status post] craniotomy, was brought to MRI. Significant artifact was noted on MRI exam. It was subsequently noted that the ETT contained a metal reinforcement coil which interfered with the MRI. The product packaging and device do not indicate that the tracheal tube contains metal and is not safe for MRI scanning.

Device:
Type: Laryngeal Mask
Manufacturer: Anesthesia Equipment Supply, Inc
Brand: Aes Ultra Flex Cpv
Lot #: DG12117108
Cat #: 1037225

Problem:
LMA [Laryngeal Mask Airway] was tested prior to use by Anesthesiologist. Cuff on AES Ultra Flex CPV LMA (size 2.5, Lot # DG12117108) would not hold air once inflated. A total of 7 LMAs were tested & failed prior to finding one that worked. All were from same lot as listed above. As a result, remaining LMAs with this lot # were pulled from stock. We have been using these LMAs for approximately 2 years. We have not seen this issue previously.

Device:
Type: One-way Valve
Manufacturer: CareFusion 211
Brand: Airlife
Model#: 001800
Lot #: Y10S0086
Cat #: 001800

Problem:
During a pulmonary function test, albuterol was being administered through a one-way valve. During the inhalation, the soft movable piece of the valve separated from the device and was inhaled by the patient. Patient complained of initial discomfort but an attempt to recover the valve material through bronchoscopy was unsuccessful. Patient regained a feeling of normalcy, possibly having coughed up and swallowed the material.
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Manufacturer response for One-way valve, AirLife
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None as yet.

See device image:




Device:
Type: Oxygen Flowmeter
Manufacturer: Precision Medical Inc.
Brand: Oxygen Flowmeter
Model#: 2MFA1001
Other #: date code 5-95

Problem:
Nurse noticed something was not right with the flow meter and asked the charge nurse to check the flow meter. The patient was on an oxygen face mask connected to the flow meter involved in the incident. As the charge nurse entered the room she noticed that it smelled like something was burning. She observed that the flow tube was black. She had Respiratory Therapy paged to come to the room. She then began to turn down the flow meter, as she was adjusting the flow meter, it exploded and flames began to shoot out of the wall. A code red was initiated via the phone. The patient was immediately evacuated from the room and the door to the room was closed. The nursing supervisor turned off the oxygen to half of the unit. Security extinguished the burning pieces. There was no patient harm, employee injury or damage to the facility. Flowmeter had been in use for almost 4.5 days before this reported event occurred.
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Manufacturer response for Oxygen Flowmeter, Oxygen Flowmeter
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I spoke with Precision Medical representative. He took down my information and a summary of what occurred. He made a reference that there was a recall on this device in the late 1990's. He was going to research the previous recall. He mentioned that this was the first incident with this device that he was aware of in his 10 years with the company.

Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: GE
Brand: Engstrom Carestation
Model#: 1505-9000-000
Cat #: 1505-9000-000

Problem:
Unit shut down during transport of a patient. During biomed testing, the unit was turned on with the power cord plugged in. Ventilator was in stand-by mode. The ventilator was then unplugged from AC power. The LED for power turned off but the unit did not show that it was running on battery power ("On battery" dialog box and green battery symbol on graphic display did not present). Furthermore, the device did not produce the appropriate audible tone signifying disconnection from AC power. After about 2 minutes the ventilator shut down and the alarm did not sound for another 10 seconds.


CARDIOVASCULAR

Device:
Type: Physiological Monitor, Mri, Ecg Module
Manufacturer: MedRad, Inc.
Brand: Veris
Model#: 8600
Cat #: 3010459

Problem:
Thursday evening about 9:00 pm, the device was disconnected from its battery charger and placed at the foot end of the table of the Siemens Espree MRI scanner in preparation for the arrival of an ICU patient. That patient was kept in the hallway outside the room while their IV lines were being switched over to two MR compatible pumps, one of which encountered an unexpected air-in-line condition causing a delay. During that delay, the ECG module started to smolder and quick-thinking staff removed it from the exam room and called a Code Red. There was no harm to the patient or staff. The principle concern, however, is that the device has a short lead set so that when it is connected to the electrodes on a patient's chest, it is then laid on the chest and connected via a fiberoptic cable to the actual display monitor. A tech grabbed the smoldering device by the lead set and took it down a different hallway and placed it on another MR table that is kept there. A little later, he moved it to the floor. The smoke from the device did not set off the smoke detectors. (I found a reference to the company Nexergy on the charger.) The event was clearly the result of some kind of battery failure but we don't know the exact nature.
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Manufacturer response, according to reporter, for Physiological Monitor, MRI, Interface, Veris:
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They checked their records and tell us this has not happened anywhere or at anytime before.

See device images:





Device:
Type: Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer: Abbott Vascular
Brand: Viatrac 14 Plus Peripheral Dilation Catheter
Lot #: 0051151
Cat #: 1008193-20

Problem:
During the procedure the surgeon took the post dilated balloon and dilated it up to 12 atmospheres and the balloon burst, leaving fragments of the balloon on the wire. The surgeon was unable to get the fragments to come into the shuttle sheath. After several attempts the surgeon was able to get the shaft of the balloon out. The surgeon then took out the shuttle sheath and advanced an introducer sheath and was then able to snare all of the remaining balloon fragments and the embolic protection system. The surgeon successfully removed the balloon fragments without complications to the patient.

Device:
Type: Catheter, Flow Directed
Manufacturer: Edwards Lifesciences
Brand: Swan-Ganz, Vip
Model#: 831HF75
Cat #: 831HF75

Problem:
I spoke with the nurse in the ICU who had the Swan-Ganz catheter. She stated, when the patient first arrived and was hooked up to the physiological monitors, the temperature would register normal thermal 98 degrees. After awhile it would slowly creep up until it registered 104 degrees. She said that they took the tympanic temperature, temple, and orally and they were normal thermal. She even checked the patient to make sure they did not feel warm. She said they changed the cables, module and used a different monitor. None of these changes made a difference.
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Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP:
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Sending box in to return and sending a replacement. Will also send report after examination of product.


Device:
Type: Clamp, Vascular
Manufacturer: St. Jude Medical (Radi)
Brand: Femostop Gold Sheath
Cat #: 11165

Problem:
Two RNs from cath lab at bedside to discontinue femoral sheath. Femostop applied per protocol and sheath was removed without incident. After approximately ten (10) minutes, when pressure was to be reduced by use of the manometer on Femostop, they were unable to do so. Pressure was reduced by loosening Femostop belt. No bleeding at site. Pedal pulses palpable. After 30 minutes Femostop was removed and a wedge dressing was applied as in hand-held protocol. After removal from the patient, the nurses were still unable to deflate the pressure pad on the Femostop. Cath checks were completed without bleeding or hematoma.

Device:
Type: Clamp, Vascular
Manufacturer: Maquet
Brand: Heartstring Iii Proximal Seal System
Model#: HSK-3038
Lot #: 25023772

Problem:
Scrub tech attempted to load the Heartstring III and it would not load properly.

Device 1:
Type: Device, Hemostasis, Vascular
Manufacturer: Abbott Laboratories
Brand: Proglide Suture Mediated System
Lot #: 8500164
Cat #: 12673

Device 2:
Type: Device, Hemostasis, Vascular
Manufacturer: Abbott Laboratories
Brand: Proglide Suture Mediated System
Lot #: 8500164
Cat #: 12673
Problem:
The surgeon attempted to tie down the Perclose sutures but the right side failed to seal. On the left side one suture went down and the other suture pulled out. The surgeon performed bilateral femoral artery cutdowns and proximal distal control was obtained on the common femoral profunda femoris and superficial femoral arteries and the arteriotomy was closed with multiple interrupted 5-0 Prolene sutures.


EAR, NOSE, & THROAT

Device 1:
Type: Nerve Stimulator
Manufacturer: Medtronic
Brand: NIM
Model#: NIM 2.0

Device 2:
Type: Nerve Stimulator
Manufacturer: Medtronic
Brand: NIM

Problem:
After the first surgery, surgeon #2 made a complaint to the OR manager stating that he wanted the NIM's checked out since the probe function was questionable during the procedure. He stated the patient could have nerve damage, but that the patient had promising signs of eye blinking. At that time it could not be identified which of two owned NIM's was used. Both NIM's were sent to our BioMed department who reported "Setup and tested both units per manufacturers checklist. All tests passed...no problems indicated." Neurosurgeon assessment after surgery #1 indicated right facial weakness. Surgeon #2 noted complete eye closure with effort, no nystagmus in primary or lateral gaze. Facial nerve had good prognosis. Since the complaint from surgeon #2 was made, we made a decision to keep both NIM's out of service until we could determine if the patient was affected. Surgeon #2 told us that he "feels" the patient was injured because of this NIM. He said he has problems with the old NIM's of the same model. He said he had just had a problem the day before at a neighboring children's hospital with the same model of the NIM's. He feels all the older NIMs are having issues. He said he reported multiple concerns from three other hospitals to Medtronic Representative. The surgeon said that all the problems were with the "old" equipment models and that other hospitals needed to buy the newer model as the new model is more "sensitive." Per neurosurgeon in discharge summary, the patient's discharge condition was improved. There is no way to definitely determine if the patient was impacted.


GENERAL & PLASTIC SURGERY

Device:
Type: Clip Applier
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Ligaclip
Model#: ER320
Other #: size M/L

Problem:
Operating staff report patient undergoing laparoscopic cholecystectomy. Upon the surgeon using the Ethicon Ligaclip Endoscopic Rotating Multiple Clip Applier the applier deployed too many clips with firing of the device. All clips accounted for but not retained. Surgeon utilized a different clip applier to finish the procedure. No injury or harm to the patient. Patient was sent to PACU for recovery. Original clip applier was removed from the field and sequestered for Risk Management pick up.


Device:
Type: Gauze, Sponge
Manufacturer: Covidien
Brand: Vistec
Model#: 7318
Lot #: 100000071062

Problem:
Debris observed inside sterile package during room set-up. There was no patient impact.

See device image: