Highlighted Reports
MedSun: Newsletter #47, April 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 January 1 through January 31 2010. 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: Co2 Detector
Manufacturer: Covidien Nellcor
Brand: Easy-cap Ii
Model#: (not provided)
Lot #: 7334108
Cat #: (not provided)
Other #: (not provided)

Problem:
Burn patient required intubation. Burn MD intubated patient and used a Nellcor Easy Cap II Co2 detector to determine if tube was properly inserted and patient was correctly intubated. Co2 detector did not change color to indicate proper ventilation of patient. MD retracted the tube, thinking the tube was incorrectly placed and then reapplied the Co2 detector again to check for proper ventilation. Again, the detector did not change colors as it should. MD tried once more with the same result, no change in detector color. At this point the MD asked for and used another Co2 detector which quickly changed color to indicate proper ventilation of the patient. After the third intubation and patient was secured, MD questioned if the Co2 detector was defective. MD felt the multiple intubations (3) did cause some additional swelling to patient’s airway. Patient remained intubated in unit recovering from her severe burns.


Device:

Type: Oscillator Vent
Manufacturer: CareFusion SensorMedics
Brand: Sensormedics 3100b
Model#: 3100B
Lot #: (not provided)
Cat #: 3100B

Problem:
Patient was being treated with the oscillator vent when it was reported by an anonymous user that during a patient handoff, the patient coughed and the surround/diaphragm speaker had blown out. The disposables were not sequestered. There was no patient harm. The patient was placed onto a ServoI vent in response to the equipment failure. We have sequestered the vent and have begun to investigate the complaint and initiate a repair.

Manufacturer response (as per reporter) for Oscillator Vent, Sensormedics 3100B

They have had a large number of these failures recently. They are questioning cleaning chemicals and have seen a sharp increase in failures with H1N1. They may change their spec to require premature replacement of the driver component and reduce their spec from 4000hrs to 2000hrs.


Device:

Type: Tracheostomy Tube, Disposable Cannula, Low Pressure, Cuffed
Manufacturer: Covidien Shiley
Brand: Shiley Dct8 Cuffed
Model#: 8 DCT (size)
Lot #: 0903001434
Cat #: CE0123
Other #: (not provided)

Problem:
Approximately 3 hours after initial tracheostomy, audible leak was heard from trach site. Respiratory Therapist attempted to correct the leak and patient then returned to the OR for replacement of Trach tube with new size 8. This was the 6th tracheostomy tube with leak (4/6 with ruptured balloon) since August 2009. Issue previously reported to MedSun. The 4/6 trach tubes were from same Shiley size # 8 Lot size and remainder of stock from this lot have been removed from shelf. Manufacturer aware.

Manufacturer response (as per reporter) for Disposable cannula low pressure cuffed tracheostomy tube, Shiley:

Manufacturer reached out to the local Shiley representative and requested he contact the hospital.


Device 1:

Type: Vapotherm Patient Circuit
Manufacturer: Vapotherm Inc.
Brand: Vapotherm Patient Circuit
Model#: PF-DPC-LOW
Lot #: 09120710350
Cat #: PF-DPC-LOW
Other #: (not provided)

Device 2:

Type: Vapotherm Patient Circuit
Manufacturer: Vapotherm Inc.
Brand: Vapotherm Patient Circuit
Model#: PF-DPC-LOW
Lot #: 09112510307
Cat #: PF-DPC-LOW
Other #: (not provided)

Problem:
When patient circuit was attached to the filter box of a Vapotherm Precision Flow humidifier it did not click in so it came loose and it leaked water. The event was discovered because of water leaking from the connection onto the floor. The only way we could have prevented it was to make sure the circuit is completely pushed in and the clip that holds the circuit clicks in, but staff does not feel this would totally fix the problem.

Manufacturer response (as per reporter) for Vapotherm Patient Circuit, Vapotherm Patient Circuit

Manufacturer provided RGA# for product return evaluation.


CARDIOVASCULAR

Device:

Type: Catheter, Ablation, Rf, Cardiac
Manufacturer: Biosense Webster
Brand: Navistar Thermocool
Model#: (not provided)
Lot #: 15002294
Cat #: NI75TCFH
Other #: (not provided)

Problem:
Carto imaging of the catheter tip was backwards. The catheter was wired improperly. The catheter was replaced with a new one and the problem was resolved. The replacement packaging from the second catheter was not saved for lot comparison. There was no injury to the patient. This is the first time we have seen this type of problem.


Device:

Type: Catheter, Arterial, Radial
Manufacturer: Teleflex Medical
Brand: Radial Artery Catheterization Set
Model#: (not provided)
Lot #: CF8096562
Cat #: RA-04122
Other #: (not provided)

Problem:
The anesthetist was attempting to place a radial artery catheter in a child. The artery was not cannulated but as he tried to remove the catheter he was unable to withdraw the device from the patient. Eventually most of the device withdrew but approximately 1 inch of the catheter containing the broken wire was retained in the patient. The catheter broke off at skin level and part of the catheter and stylet were retained under the skin. The surgeon did a small cut-down to remove the retained arterial catheter and stylet.

A second kit of the same lot number was opened to make a second attempt at placement. It was examined before the attempt and found to be defective. Withdrawing the stylet wire from the needle resulted in approximately 1 inch of wire left protruding from the needle. This kit was not used on the patient.


Device:

Type: Defibrillator, Crt
Manufacturer: Medtronic Inc.
Brand: Concerto
Model#: C154DWK
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The patient has a history of nonischemic dilated cardiomyopathy with severely depressed left ventricular systolic function (most recent EF 25% to 30% on echocardiogram one and a half years ago), chronic left bundle-branch block with QRS duration of 148 milliseconds and New York Heart Association class III heart failure symptoms (historically). She underwent implantation of a Medtronic dual-chamber, biventricular ICD over three years ago. Her right ventricular (RV) and left ventricular (LV) lead thresholds were noted in time to be significantly elevated, requiring high-output pacing. Additionally, her Medtronic Concerto CRT-D reached premature elective replacement interval but does not appear to be part of the recent recall. Her right ventricular lead was Sprint Fidelis, model 6949, and was noted on routine follow up to have decreased sensing, in addition to elevation in thresholds. Her LV lead was in the anterior interventricular branch pacing the anterior septum. She presented for lead revision and new generator placement. There was no injury to the patient.


Device 1:

Type: Defibrillator, External
Manufacturer: Philips Medical Systems
Brand: Heartstart Xl
Model#: M4735A
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Paddles, Switched, Defibrillator, Internal
Manufacturer: Philips Medical Systems
Brand: (not provided)
Model#: M4743A
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The OR staff report there was a patient in the OR for chest re-exploration. As the chest was opened, the patient converted to ventricular fibrillation. Internal chest paddles were connected to the machine and they would not fire. The doctor tried multiple times and the paddles would never fire. The paddles were replaced and still could not get a new set to fire. The defibrillator machine was replaced with another Philips HeartStart XL and finally able to get a charge across the heart using the second set of paddles. There was no delay in maintaining perfusion as the patient was intubated and maintaining blood pressure with anesthesia assistance. The surgeon was massaging the heart for "maybe two minutes" until the defibrillator worked and was able to proceed. The unit and paddles were removed from service and sent to Clinical Engineering. The unit and paddles will NOT be placed back into service. The patient had successful surgery with bleeding of heart stopped and was sent to ICU/CVCU. He was then weaned from the vent and was maintaining good hemostasis as well as being alert and oriented. The patient continued to do well and was discharged home. The defibrillator and both sets of internal paddles were tested in biomed per manufacturer and passed. No error messages were noted on the error log of the defibrillator and there was never a message displayed that the internal paddles were not connected.


Device 1:

Type: Lead, Defibrillation
Manufacturer: Medtronic Inc., Cardiac Rhythm Disease Management
Brand: Sprint Fidelis
Model#: 6949
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Lead, Left Ventricular
Manufacturer: Medtronic Inc., Cardiac Rhythm Disease Management
Brand: Attain Otw
Model#: 4194-88
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The patient has a history of nonischemic dilated cardiomyopathy with severely depressed left ventricular systolic function (most recent EF 25% to 30% on echocardiogram one and a half years ago), chronic left bundle-branch block with QRS duration of 148 milliseconds and New York Heart Association class III heart failure symptoms (historically). She underwent implantation of a Medtronic dual-chamber, biventricular ICD over three years ago. Her right ventricular (RV) and left ventricular (LV) lead thresholds were noted in time to be significantly elevated, requiring high-output pacing. Additionally, her Medtronic Concerto CRT-D reached premature elective replacement interval but does not appear to be part of the recent recall. Her right ventricular lead was Sprint Fidelis, model 6949, and was noted on routine follow up to have decreased sensing, in addition to elevation in thresholds. Her LV lead was in the anterior interventricular branch pacing the anterior septum. She presented for lead revision and new generator placement. There was no injury to the patient.


Device:

Type: System, Thermal Regulating
Manufacturer: Cincinnati Sub zero
Brand: Maxi Therm Lite
Model#: (not provided)
Lot #: 769042
Cat #: 876
Other #: (not provided)

Problem:
Patient using Blanketol III with Maxi-therm Lite blanket. Blanket on top of patient noted to be leaking and saturating patient's gown. Nurse noticed that outer coating of blanket appeared to be coming apart. Blanket was saved.


Device 1:

Type: System, Thermal Regulating
Manufacturer: Arizant Healthcare
Brand: Bear Paws
Model#: 875
Lot #: (not provided)
Cat #: (not provided)
Other #: 110-120vac-50/60 Hz; 4.6A

Device 2:

Type: System, Thermal Regulating
Manufacturer: Arizant Healthcare
Brand: Bear Hugger
Model#: 500 OR
Lot #: (not provided)
Cat #: Ref 50201 Rev H
Other #: (not provided)

Device 3:

Type: Warming Gown
Manufacturer: Arizant Healthcare
Brand: Bear Paws Flex
Model#: 810
Lot #: GU1025
Cat #: Ref 81003
Other #: (not provided)

Problem:
Staff reported several instances of patients having red 'splotches' on anterior skin surfaces when the Bear Paws Flex gown is removed following surgery. Information in this report refers to the latest incident, when it was reported that the gowns were being removed from service pending investigation. Prior instances were not able to be identified and verified.

Details in this case:
Patient used gown in holding area with Bear Paws machine. In OR, switched to Bear Hugger. Temp set on high (std practice). Length of procedure approx 2 1/2 hours. When gown removed at the end of the procedure, red splotchy areas were noted on the patients lower abdomen, left groin and left anterior thigh. The hose was found properly connected to the gown. There were no blisters noted. The areas were painless. They faded after approximately 8 hours without treatment.



CLINICAL CHEMISTRY

Device:

Type: Tray, Lumbar
Manufacturer: Cardinal Health
Brand: Cardinal
Model#: (not provided)
Lot #: L9J201
Cat #: 4301C
Other #: (not provided)

Problem:
In preparation for a lumbar puncture, the staff noticed a hole in the cap of the tube. The tray was set aside and another tray was opened. Also, there was a hole in the cap of this tube as well. Both lumbar puncture trays came from the same lot number.


GASTROENTEROLOGY & UROLOGY

Device:

Type: Hemodialysis Machine, Continuous Renal Replacment Therapy
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model#: (not provided)
Lot #: n/a
Cat #: n/a
Other #: n/a

Problem:
While changing the effluent drainage bag, the computer screen on the Prismaflex CRRT (continuous renal replacement therapy) machine froze, causing a scale malfunction that shut off the blood pump. I was unable to restart the blood pump after attempting to "retest" the scale function several times. The patient lost approximately 200 cc's of blood remaining in the system. This filter had been up and running only 15 hours prior to this.


GENERAL & PLASTIC SURGERY

Device:

Type: Carrier, Skin Graft
Manufacturer: Zimmer
Brand: Dermacarrier Ii
Model#: (not provided)
Lot #: 61036899
Cat #: 00-2195-012-00
Other #: (not provided)

Problem:
The mesh carrier that the skin graft is placed on and then placed through the meshing device caused the graft to be shredded, making it unusable. When looking at carrier it was obvious that the "grid" was not the same as the other carrier in the box. The defective carrier was the last one in the box, nothing to compare it to. The graft was placed on the correct side of the carrier.


Device:

Type: Electrosurgical Unit
Manufacturer: Conmed Electrosurgery
Brand: System 5000
Model#: 60-8005-001
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Device comes from manufacturer with set up option set to "Last Setting". In this mode when device is turned on, all power settings revert to levels of last use. This could be the previous case that day, previous case that week or whenever it was last used. This caused a near miss incident when an operator set the cut mode to one power level, then changed to a blend not noticing that the power level increased appraisable, to a level last used. In the incident investigation it was found that this device had been inspected by Clinical Engineering very recently. The conclusion from Clinical Engineering was that the memorized "Last Setting" in the blend mode was the result of testing max power out during the inspection. The device has an internal option to have at power up, to have all power settings set to zero. This is not a user settable option; it is an internal mechanical setting. Two procedural changes have been adopted:

1. All like devices in house have had the internal option setting to power-up to a zero power level by Clinical Engineering.

2. At the completion of interval testing by Clinical Engineering for all Electrosurgical Units, all power settings will be set to zero before being returned to service.


GENERAL HOSPITAL

Device:

Type: Iv Tubing, Connector, Male
Manufacturer: ICU MEDICAL
Brand: Spiros Closed Male Connector
Model#: REF#CH2000
Lot #: 1717298
Cat #: (not provided)
Other #: (not provided)

Problem:
Doxorubicin 23mg/11.5mL hung at a rate of 20mL over 1hr. Doxorubicin came up in syringe with Spiros attached to end and given via syringe pump. Approximately 20 minutes later, Doxorubicin was noted to be leaking from syringe/Spiros. It had pooled on the pump dripped down on the floor. Nurse touched the pump inadvertently and Doxorubicin dripped on her hand. She washed her hands immediately with soap and water and an injury report was completed. No Doxorubicin had reached the patient. Approximately 4-7mLs of Doxorubicin were lost. Chemo spill kit used per policy and procedure. Equipment wiped down as well. Environmental notified and cleaned area. No injury to patient.


OBSTETRICS/GYNECOLOGY

Device:

Type: Bed, Hospital, Birthing
Manufacturer: Hill-Rom Company, Inc.
Brand: Affinity
Model#: AFFINITY
Lot #: NA
Cat #: NA
Other #: NA

Problem:
Patient's husband was sitting on the bottom half of the labor bed, and the bed broke out from under him and he fell onto the floor.

See device images
Affinity Labor Bed Image

Affinity Labor Bed Bottom Half

Affinity Labor Bed Locking Screw


RADIOLOGY

Device 1:

Type: Imaging Coil, Cardiac, 6Channel, 3t
Manufacturer: Philips Medical Systems
Brand: (not provided)
Model#: 43567009711
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Mri, 3t
Manufacturer: Philips Medical Systems
Brand: Achieva 3t
Model#: Release 2.6.3.4
Lot #: (not provided)
Cat #: (not provided)
Other #: Site ID# 505048

Problem:
Patient was getting an MRI scan involving her pelvis when patient complained of a burning sensation on her left side. The patient squeezed the emergency ball and two technologists went in to investigate. The patient had redness to the skin and the apparatus used in the procedure was quite warm. On site personnel from Philips were called as well as our on physicist was notified.

The coil in use when the patient complained of heat was the 6 channel cardiac coil for the clinical 3T scanner. This coil was immediately removed by the techs for the completion of the scan. The Philips service engineer and I inspected the coil. There was visible wear at one of rf balun components. The service engineer removed the plastic covering of this balun to reveal that the solder around ground shield sleeve was mechanically broken essentially around the entire circumference of the sleeve. I speculate the high impedance path to ground at this failure point was the source of heating felt by the patient. The coil was removed from service for repair/replacement by Philips.


Device:

Type: Mri, 1. 5t
Manufacturer: GE Medical Systems, LLC
Brand: (not provided)
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was in MRI for cervical spine MRI. During test she informed the tech that she felt a burning sensation on her right forearm. She was removed from the MRI and the tech looked at her arm. There was no indication that there was anything wrong. The patient's arms were covered, and they completed the test. She contacted the department two days later, stating that she had a blister on her right forearm. She was examined by the Radiology Resident on that date.

It is believed that the patient's skin may have been in contact with the inside of the MRI device without padding or protection.


Device:

Type: Ultrasound Unit, Diagnostic
Manufacturer: Sonosite
Brand: Micromaxx
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was set to undergo an emergency C-section. Physician requested confirmation of fetal heart tones prior to start of the procedure. Ultrasound was ordered. While doing this test the machine alarmed with an error message. The message said, "Error" and nothing more. The physician was not able to obtain the readings that were needed. Patient at 24 weeks with twins. One twin was a live birth; second twin with fetal demise. There is no evidence linking the death of the twin to the equipment failure.

Equipment was removed from patient and BioMed was alerted. BioMed came and sequestered the device. Call placed to manufacturer who explained that they did not know what the "Error" message meant. Manufacturer is requesting that the device be returned to them for evaluation. Risk Management is requesting that device be held at hospital until more details are available.


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