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U.S. Department of Health and Human Services

MedSun: Newsletter #80, January 2013

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Newsletter #80, January 2013

Articles

Bunnell Life Pulse High-Frequency Ventilator Patient Circuits: Recall

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FDA MedWatch Safety Alert

This product has been found to have heater wire insulation that can melt, causing sparking and smoke, close to the humidifier cartridge. This can cause serious adverse consequences, including death. On November 19, 2012, Bunnell sent its customers an urgent medical device recall notification letter by certified mail.

Additional Information:

FDA MedWatch Safety Alert. Bunnell Life Pulse High-Frequency Ventilator Patient Circuits: Recall. December 21, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333262.htm

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Ventlab Adult and Pediatric Manual Resuscitators: Recall

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FDA MedWatch Safety Alert

The affected manual resuscitators may have a valve leak which prevents the flow of air/oxygen to the patient. This lack of airflow to the patient may not be easily observable to the user because the bag still deflates when compressed. Lack of air/oxygen can cause life-threatening health consequences for patients, including hypoxia, hypoventilation or death.

Additional Information:

FDA MedWatch Safety Alert. Ventlab Adult and Pediatric Manual Resuscitators: Recall. December 21, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333261.htm

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Medtronic Drug Infusion Pumps: Recall

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FDA MedWatch Safety Alert

FDA and Medtronic notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the pump’s performance. The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. Do not use compounded drugs, unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Drug Infusion Pumps: Recall. December 21, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333251.htm

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Verathon GlideScope Video Laryngoscope Reusable Blades: Class 1 Recall

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FDA MedWatch Safety Alert

The GlideScope GVL Video Laryngoscope Resuable Blades are being recalled due to potential cracking and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in a patient’s mouth and obstructing the airway or being swallowed, which may cause serious adverse health consequences, including death. The affected GlideScope GVL blades are at risk of developing stress cracks at the blade tip that may not be readily visible during routine inspection prior to intubation.

Additional Information:

FDA MedWatch Safety Alert. Verathon GlideScope Video Laryngoscope Reusable Blades: Class 1 Recall. December 13, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332121.htm

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Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of the Olympic Cool-Cap System, because the device's Control Module may experience a frozen screen during treatment. When this occurs, the on-screen information remains on display, but the system is not providing cooling treatment to the infants. All serial numbers are affected by this recall.

Additional Information:

FDA MedWatch Safety Alert. Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall. December 12, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331853.htm

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Highlighted MedSun Reports

Highlighted Reports

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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 October 2012. 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.


Device:
Type: EKG 5Lead Set
Manufacturer: Philips Medical Systems
Brand: Telemetry Lead
Model#: 989803171851

Problem:
Lead sets have a gasket on connector which sometimes pulls out when leads are disconnected from Tranceiver. Upon reconnection, gasket prevents electrical contact resulting in a "leadset unplug message" and patient monitoring ceases. 24 of the original 140 lead sets had problem since June 2012 installation. Manufacturer states it will only replace lead sets that fail and will not exchange all 140 with corrected product.


Device:
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: 3M
Brand: 3m Universal Electrosurgical Pad
Model#: 9160
Lot #: 2015-08JX

Problem:
Bovie grounding pad placed on patient during initial neurosurgical procedure. Transferred to Critical Care and then returned to surgery several days later. Surgery staff found the grounding pad still affixed to the patient's skin. The white, soft cover to the pad was thought to be a surgical dressing and not removed by CCU staff. There was a potential for skin damage due to prolonged placement; fortunately no damage occurred. If the pad covering was a color other than white, staff may have recognized it as something to remove.


Device:
Type: Electrosurgical, Cutting &Coagulation &Accessories, Cutting Forceps
Manufacturer: Gyrus ACMI, Inc.
Brand: Gyrus Ent
Model#: G400
Lot #: 470199FE

Problem:
At the beginning of the month, OR staff reported an intermittent problem with a Gyrus G400 RF generator not delivering energy during a case. Different cutting forceps were tried and worked for a while but failed again. However, G400 generator would look and sound like energy was being delivered normally. Cutting forceps were saved for the rep to examine. The rep came in with an engineer from Gyrus and marketing manager who is in charge of the energy division to observe cases and verify problem. At a later date, the rep informed OR staff that Gyrus identified a problem with a particular circuit in the cutting forceps. As such, staff was told cutting forceps manufactured after the beginning of this month will have updated circuitry to correct identified issue of ceasing to deliver energy peri-operatively.


Device:
Type: Electrosurgical, Cutting &Coagulation &Accessories, Cutting Forceps
Manufacturer: Gyrus ACMI, Inc.
Brand: Gyrus Ent
Model#: G400
Lot #: 428982CE

Problem:
At the beginning of the month, OR staff reported an intermittent problem with a Gyrus G400 RF generator not delivering energy during a case. Different cutting forceps were tried and worked for a while but failed again. However, G400 generator would look and sound like energy was being delivered normally. Cutting forceps were saved for the rep to examine. The rep came in with an engineer from Gyrus and marketing manager who is in charge of the energy division to observe cases and verify problem. At a later date, the rep informed OR staff that Gyrus identified a problem with a particular circuit in the cutting forceps. As such, staff was told cutting forceps manufactured after the beginning of this month will have updated circuitry to correct identified issue of ceasing to deliver energy peri-operatively.


Device:
Type: Electrosurgical, Cutting &Coagulation &Accessories, Cutting Forceps
Manufacturer: Gyrus ACMI, Inc.
Brand: Gyrus Ent
Model#: G400
Lot #: 464892FE

Problem:
At the beginning of the month, OR staff reported an intermittent problem with a Gyrus G400 RF generator not delivering energy during a case. Different cutting forceps were tried and worked for a while but failed again. However, G400 generator would look and sound like energy was being delivered normally. Cutting forceps were saved for the rep to examine. The rep came in with an engineer from Gyrus and marketing manager who is in charge of the energy division to observe cases and verify problem. At a later date, the rep informed OR staff that Gyrus identified a problem with a particular circuit in the cutting forceps. As such, staff was told cutting forceps manufactured after the beginning of this month will have updated circuitry to correct identified issue of ceasing to deliver energy peri-operatively.


Device:
Type: Monopolar Curved Scissors
Manufacturer: Intuitive Surgical
Brand: Endowrist Hot Shears
Lot #: M10120711 637
Cat #: 420179

Problem:
During the procedure, the surgeon noted the instrument was arcing unintentionally, and burned the uterus. The tip was changed out and it continued to arc. A new instrument was opened and functioned with no problems. It is unknown if the new instrument was of the same or a different lot.

======================
Manufacturer response for Monopolar Curved Scissors, da Vinci Monopolar Curved Scissors (per site reporter)
======================
They want the device back within a very short period of time or they reserve the right to cancel the RMA without notice.


Device:
Type: Patient Circuit, Tubing, High Frequency, Oscillating Ventilator
Manufacturer: CareFusion, 2200, Inc.
Brand: 3100a Hfov Circuit
Cat #: 771375
Other #: 3100A HFOV Unfiltered Circuit

Problem:
While Respiratory Therapy was performing the Patient Circuit Calibration procedure they were having a difficult time getting any of the Oscillators to pass. Upon further inspection by the Biomedical Instrumentation Department, they found that the port on the left hand side of the CareFusion patient circuit (i.e. the green tubing control side when facing the Oscillator), the port appears to be irregular. The housing for the cap diaphragm plastic mold has a defect in it that can be seen with the eye. The affected circuits are CareFusion # 771375 which is for use with the Fisher & Paykel heater # MR730, and the CareFusion # 773997 which is for use with Fisher & Paykel heater # MR850.

Several caps supplied by CareFusion were tried and we were able to get one or two to work after playing with it. Samples of the defective product were provided to the representative from CareFusion who acknowledged the defect.

Unfortunately we have not heard back from CareFusion that they are addressing the problem. In the meantime, clinicians are taking valuable time away from patient care trying to get these units to calibrate.

No concern at present with the Fisher & Paykel heater.
CareFusion circuits are disposable and packaging samples are saved.
Circuits are not a reprocessed item used on more than one patient.
Circuits were returned to the manufacturer.
Additional circuits are available at our facility for evaluation.


Device:
Type: Patient Circuit, Tubing, High Frequency, Oscillating Ventilator
Manufacturer: CareFusion, 2200, Inc.
Brand: 3100a Hfov Circuit
Cat #: 773997
Other #: 3100A HFOV Unfiltered Circuit

Problem:
While Respiratory Therapy was performing the Patient Circuit Calibration procedure they were having a difficult time getting any of the Oscillators to pass. Upon further inspection by the Biomedical Instrumentation Department, they found that the port on the left hand side of the CareFusion patient circuit (i.e. the green tubing control side when facing the Oscillator), the port appears to be irregular. The housing for the cap diaphragm plastic mold has a defect in it that can be seen with the eye. The affected circuits are CareFusion # 771375 which is for use with the Fisher & Paykel heater # MR730, and the CareFusion # 773997 which is for use with Fisher & Paykel heater # MR850.

Several caps supplied by CareFusion were tried and we were able to get one or two to work after playing with it. Samples of the defective product were provided to the representative from CareFusion who acknowledged the defect.

Unfortunately we have not heard back from CareFusion that they are addressing the problem. In the meantime, clinicians are taking valuable time away from patient care trying to get these units to calibrate.

No concern at present with the Fisher & Paykel heater.
CareFusion circuits are disposable and packaging samples are saved.
Circuits are not a reprocessed item used on more than one patient.
Circuits were returned to the manufacturer.
Additional circuits are available at our facility for evaluation.


Device:
Type: Pta Dilation Catheter
Manufacturer: Cordis (a Johnson & Johnson company)
Brand: Savvy
Lot #: 15536462
Cat #: 435-606 L

Problem:
A Savvy PTA (percutaneous transluminal angiographic) dilatation catheter (6.0mm x 6cm) manufactured by Cordis was prepped and placed into the patient through a sheath. It was appropriately inflated with an inflation device. For this balloon, the nominal pressure rate is 6 atm and the burst pressure rate is 10 atm. However, the balloon ruptured at 5 atm. A second Savvy 6.0mm x 6cm was properly prepped, inserted and inflated. It too ruptured, this time at 8 atm. The catheters were from the same lot number. There was no harm to the patient.


Device:
Type: Pta Dilation Catheter
Manufacturer: Cordis (a Johnson & Johnson company)
Brand: Savvy
Lot #: 15536462
Cat #: 435-606 L

Problem:
A Savvy PTA (percutaneous transluminal angiographic) dilatation catheter (6.0mm x 6cm) manufactured by Cordis was prepped and placed into the patient through a sheath. It was appropriately inflated with an inflation device. For this balloon, the nominal pressure rate is 6 atm and the burst pressure rate is 10 atm. However, the balloon ruptured at 5 atm. A second Savvy 6.0mm x 6cm was properly prepped, inserted and inflated. It too ruptured, this time at 8 atm. The catheters were from the same lot number. There was no harm to the patient.


Device:
Type: Pump, Infusion, Enteral
Manufacturer: Moog Medical Devices Group (Zevex)
Brand: Infinity Orange Small Volume
Lot #: CF1214604

Problem:
Patient uses an enteral pump for continuous feedings 22hr/day. Multiple pumps have been delivered to patient's home with same complaint-numerous alarms for 'no food' when there is food present in bag/tube. Alarms occur at least daily, often multiple times/day. Any attempt to remedy only last a short time. The manufacturer offers no explanations as to why alarms occur other than troubleshooting as printed in the handbook. Online searches for similar complaints list the new bag design as responsible for the problem. With patient's feedings, the air is purged before connecting to the pump, but during the feeding tiny air bubbles pass through the sensor and are detected causing the 'no food' alarms. No less than 6 pumps have been delivered since June of this year and many more calls have been taken by staff to manage this problem with the equipment. The patient did require additional medical care due to the interrupted feedings. Staff feel the company needs to go back to former design or create a new bag design that does not cause these problems.

The family stated that they have to 'trick' the pump into working. They have to place a paper towel in front of the sensor in order for the alarm to quit indicating that there is no food when in fact there is food in place. Staff definitely does not feel that 'tricking' the machine is safe and have instructed parents not to do this.

According to staff, this event type has occurred on more than one occasion with other patients and families. Hands-on training is provided to families prior to the family using the equipment. Handouts along with the handbook are given to staff and families.


Device:
Type: Reagent
Manufacturer: Siemens Healthcare Diagnostics Inc
Brand: Iron Flex
Lot #: 11286BA, 11319BB, 12004BB, 120
Cat #: K3085
Other #: Dimension Vista Systems

Problem:
The Department of Laboratory Medicine was informed by the manufacturer last week of the potential for falsely elevated iron results due to mineral contamination. The observed magnitude of the elevation ranges from approximately 20-800 µg/dL. The estimated rate is approximately 1 out of 2,500 samples. Iron requests from February 3rd, 2012 to the present may be affected.
Unfortunately, as the manufacturer is unable to provide the date for resolution of this issue, the DLM has temporarily instituted the policy to increase the frequency of the internal quality controls. In addition, for all iron requests as of October 9th until this issue is resolved, ferritin will be automatically measured on the same patient sample (if ferritin is not part of the initial request). The manufacturere has sent an email to the lab department earlier this month with an attached Urgent Medical Device Correction dated September 2012 informing the lab of the potential falsely elevated iron results due to environmental contamination. Siemens was not able to provide a date for resolution.


Device:
Type: Sterilization Integrator
Manufacturer: 3M Health Care Business
Brand: 3m Comply Sterigage
Model#: 1243
Lot #: 201705YG
Cat #: 1243

Problem:
3M Class 5 Emulating Integrator (1243) burst inside of a surgical instrument tray and contaminated the instruments. The instrument tray had to be reprocessed in Sterile Processing in order for the surgical case to proceed.

======================
Manufacturer response for sterilization integrator, 3M Comply SteriGage Class Steam Chemical Integrator (per site reporter)
======================
3M sent us a letter that a Corrective Action Project was put in place to identify design or manufact. improvements that could reduce the occurrence of leaking integrators...manufacturing changes have been made...preventive maintenance schedules and specs have been tightened to ensure good adhesion of the graphics to the foil and correct valve-hole placement...will continue to monitor complaints..and implement further improvements if necessary.


Device:
Type: System, X-ray, Tomography, Computed
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: (not provided)
Model#: DTC
Lot #: (not provided)
Cat #: (not provided)
Other #: Functional location # 400-082435

Problem:
The staff returned to work after the weekend and repeatedly received error messages on the screen of the device. Upon opening the panel on the device, it was noted the internal mechanisms had signs of having caught fire or otherwise having burned over the weekend. It was established the most likely explanation was the condenser leaked water onto the electrical panel. According to one staff member, the leaking has happened on other occasions in other areas with the same or similar equipment, and was reported to the manufacturer. However, this is the first report of fire damage.


Device:
Type: Table, X-ray, System
Manufacturer: Philips Healthcare
Brand: Allura Xper Table
Model#: FD10 AD7
Other #: SN#19

Problem:
At some point before or during the procedure the top right corner of the pad shifted off of the metal table. At the end of the procedure the patient was rolled onto her right side in an effort to place a slide board under her. Once her shoulder was over the implicated corner, momentum kept her rolling and she went to the floor landing on top of the nurse.


Device:
Type: Tube, Bag, Feeding
Manufacturer: Moog Medical Devices Group (Zevex)
Brand: Infinity Orange
Model#: (not provided)
Lot #: (not provided)
Cat #: INF0100
Other #: (not provided)

Problem:
Patient uses an enteral pump for continuous feedings 22hr/day. Multiple pumps have been delivered to patient's home with same complaint-numerous alarms for 'no food' when there is food present in bag/tube. Alarms occur at least daily, often multiple times/day. Any attempt to remedy only last a short time. The manufacturer offers no explanations as to why alarms occur other than troubleshooting as printed in the handbook. Online searches for similar complaints list the new bag design as responsible for the problem. With patient's feedings, the air is purged before connecting to the pump, but during the feeding tiny air bubbles pass through the sensor and are detected causing the 'no food' alarms. No less than 6 pumps have been delivered since June of this year and many more calls have been taken by staff to manage this problem with the equipment. The patient did require additional medical care due to the interrupted feedings. Staff feel the company needs to go back to former design or create a new bag design that does not cause these problems.

The family stated that they have to 'trick' the pump into working. They have to place a paper towel in front of the sensor in order for the alarm to quit indicating that there is no food when in fact there is food in place. Staff definitely does not feel that 'tricking' the machine is safe and have instructed parents not to do this.

According to staff, this event type has occurred on more than one occasion with other patients and families. Hands-on training is provided to families prior to the family using the equipment. Handouts along with the handbook are given to staff and families.


Device:
Type: Tubing, Ventilator, Oscillator
Manufacturer: CareFusion
Model#: 771465
Lot #: 0000411151
Cat #: 771465

Problem:
The circuits that attach the inspiratory limb at the heater come apart easily. This results in a leaking connection that prevents the oscillator from calibrating. While troubleshooting the calibration problems it was discovered that some diaphragm caps are not seated well.


Device:
Type: Tubing, Ventilator, Oscillator
Manufacturer: CareFusion
Model#: 771465
Lot #: 0000387562
Cat #: 771465

Problem:The circuits that attach the inspiratory limb at the heater come apart easily. This results in a leaking connection that prevents the oscillator from calibrating. While troubleshooting the calibration problems it was discovered that some diaphragm caps are not seated well.


Device:
Type: Tubing, Ventilator, Oscillator
Manufacturer: CareFusion
Model#: 771465
Lot #: 000419147
Cat #: 771465

Problem:
The circuits that attach the inspiratory limb at the heater come apart easily. This results in a leaking connection that prevents the oscillator from calibrating. While troubleshooting the calibration problems it was discovered that some diaphragm caps are not seated well.


Device:
Type: Tubing, Ventilator, Oscillator
Manufacturer: CareFusion
Model#: 771465
Lot #: 0000437562
Cat #: 771465

Problem:
The circuits that attach the inspiratory limb at the heater come apart easily. This results in a leaking connection that prevents the oscillator from calibrating. While troubleshooting the calibration problems it was discovered that some diaphragm caps are not seated well.


Device:
Type: Tubing, Ventilator, Oscillator
Manufacturer: CareFusion
Model#: 771465
Lot #: 0000455519
Cat #: 771465

Problem:
The circuits that attach the inspiratory limb at the heater come apart easily. This results in a leaking connection that prevents the oscillator from calibrating. While troubleshooting the calibration problems it was discovered that some diaphragm caps are not seated well.


Device:
Type: Tubing, Ventilator, Oscillator
Manufacturer: CareFusion
Model#: 771465
Lot #: 0000464776
Cat #: 771465

Problem:
The circuits that attach the inspiratory limb at the heater come apart easily. This results in a leaking connection that prevents the oscillator from calibrating. While troubleshooting the calibration problems it was discovered that some diaphragm caps are not seated well.


Device:
Type: Ventilator Circuit, Heated
Manufacturer: Teleflex Medical
Brand: Hudson Conchatherm Neptune
Cat #: 425-00

Problem:
The heated wires in the ventilator circuit heated up excessively resulting in the plastic circuit melting, creating a hole in the circuit. The hole in the circuit resulted in a loss of volume being delivered to the patient. The ventilator alarm sounded which alerted tech who responded to troubleshoot the ventilator. Upon inspection of the circuit it was discovered that the circuit had melted, resulting in a hole and leak in the system. The patient was BVM (bag-valve-mask)ventilated and the ventilator changed out.
The ventilator was found to be functioning correctly.
The humidifier and heated tubing are being reported.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Covidien Puritan Bennett
Brand: Puritan Bennett
Model#: 840

Problem:
During preventive maintenance (PM) inspection, found cracks on PSOL (proportional solenoid)solenoid valve on 2 of the ventilators inspected. This was noted during an annual PM where a filter within this assembly needs to be replaced as part of the PM kit. It did not fail any of the inspection testing, so there was no indication from the ventilator that the failure had occurred from any visual or audible alarm. The failure noted in all instances so far has only cracked on one-half of the collar and not completely through and through.

If it had cracked through and through, an error would have occurred that would have shut down the ventilator. No gases flow through this collar, but it does lock in the calibrated setting of this solenoid which is used by the flow sensor that is nearby in the assembly. There have been six of the thirteen (46%) we have reviewed, out of a total of twenty five ventilators owned. Clinical Engineering's recommendation will be to continue to evaluate the remaining units (twelve units), but request that all of these solenoids be replaced on our entire inventory during the time that Covidien will be evaluating to determine the root cause of the failure.

In order to assess the risk and prevent possible future failure we are working with Covidien and Respiratory department; have checked a total of 8 ventilators out of 25 and found 3 with cracked solenoids. The plan is to check the rest of the ventilators and replace all of the solenoid valves on the ventilators and have the cracked valves investigated by Covidien to avoid it from happening in the future.


Device:
Type: Ventilator, High Frequency
Manufacturer: CareFusion, 2200, Inc.
Brand: Sensormedics 3100a
Model#: 3100 A

Problem:
While Respiratory Therapy was performing the Patient Circuit Calibration procedure they were having a difficult time getting any of the Oscillators to pass. Upon further inspection by the Biomedical Instrumentation Department, they found that the port on the left hand side of the CareFusion patient circuit (i.e. the green tubing control side when facing the Oscillator), the port appears to be irregular. The housing for the cap diaphragm plastic mold has a defect in it that can be seen with the eye. The affected circuits are CareFusion # 771375 which is for use with the Fisher & Paykel heater # MR730, and the CareFusion # 773997 which is for use with Fisher & Paykel heater # MR850.

Several caps supplied by CareFusion were tried and we were able to get one or two to work after playing with it. Samples of the defective product were provided to the representative from CareFusion who acknowledged the defect.

Unfortunately we have not heard back from CareFusion that they are addressing the problem. In the meantime, clinicians are taking valuable time away from patient care trying to get these units to calibrate.

No concern at present with the Fisher & Paykel heater.
CareFusion circuits are disposable and packaging samples are saved.
Circuits are not a reprocessed item used on more than one patient. Circuits were returned to the manufacturer. Additional circuits are available at our facility for evaluation.


Device:
Type: X-ray, Dr Cassette
Manufacturer: GE Medical Systems, LLC
Brand: Optima 220r
Model#: MDL 5331287

Problem:When placing the DR cassette under a patient for chest or abdominal X-ray using the manufacturer's recommended method (handle), the Imaging staff quite frequently, inadvertently presses the power button located on the handle of the device. This delays the procedure as the cassette must be powered back on and reinitialized. Other methods of inserting the cassette are awkward and require two hands.

Placement of the unprotected power switch should be reconsidered.


Device:
Type: Monitor, Physiological, Mounting Arm
Manufacturer: GCX Corporation
Brand: GCX

Problem:
The GCX mounting bracket on the Spacelab housing broke and the housing and the modules fell. The unit is very heavy and is located above the patient's head. The nurse was unsure of what caused the mount to break as no one was moving or touching it at the time it gave way. This is the 4th module bracket to break in the critical care unit. The mounting arms that supports the Spacelab Module housing broke just above the housing at the swivel point.

The service rep for GCX Corporation came to the facility and reinforced the connection between the arm and the monitor with plastic ties.


Device:
Type: Electrosurgical Monopolar Laparoscopic Scissors
Manufacturer: Stryker Endoscopy
Brand: Peek
Lot #: 0746736D
Cat #: 250080617

Problem:
Laparoscopic scissors had an approximate 5mm break in insulated covering on shaft. During procedure, uninsulated portion of shaft came into contact with the patient's anterior abdominal wall. An area approximately 2x3cm of eschar and erythema was noted by the attending surgeon. Instrument was then taken off the sterile field and given to the equipment tech. The breach through the coating around the handpiece was visualized and saved on video. Concern expressed by attending surgeon that the tissue the energy source came in contact with was not of a type to create issue however, he expressed concern that had he been around tissue, the damage could/would have been significant including causing the likelhood of having to perform an unplanned bowel resection


Device:
Type: Surgical Pack, Custom
Manufacturer: Cardinal Health 200, LLC
Brand: Presource
Model#: sterile vascular pack

Problem:
The patient was taken to Interventional Radiology for placement of an IVC (Inferior Vena Cava) filter. After obtaining venous access, a pigtail catheter was introduced in order to obtain an inferior venacavograph prior to placing the filter. The power injector was set to a PSI of 1200 (pressure within stated limits of tubing). At the time of the injection, the distal tip separated from the catheter resulting in contrast spraying the suite. Neither the patient nor the staff were adversely exposed.

The pressure injector tubing was contained within the Cardinal Health Custom Vascular Pack.


Device:
Type: Pump, Infusion
Manufacturer: B.Braun Medical, Inc.
Brand: Infusomat Space
Model#: 8713050U
Other #: BMI# 23958

Problem:
Infusion pump was set up with 40 mL bag of Fentanyl solution and rate started at 3.54 mL/hr. Over the next 3 hours, the rate was manually decreased until the nurse noticed that the bag was virtually empty. The nurse calculated that there should have been over 31 mL remaining.

The patient was on CPAP/PS ventilator support, so ventilator was changed to mandatory RR. Reversal medication (Narcan) was given and observation continued. No other consequences occurred.
Upon inspection, the pump tested OK and its electronic event log agreed with reported settings. The log indicated a total of 9.97 mL delivered during the infusion time.

Three family members had been in the room, in addition to the nurse and a student nurse, during the time of the infusion. It is unknown what happened to the missing solution.


Device:
Type: Pump, Infusion
Manufacturer: B.Braun Medical, Inc.
Brand: Infusomat Space
Model#: 8713050U

Problem:
Patient's infusion finished late, and two users reported differing rate settings for the pump.

The pump's electronic history confirmed a rate change from the expected value of 17 mL/hr to 5.63 mL/hr. The change was the result of the nurse changing the Time remaining for completion. When the tubing set was changed, the nurse restarted the pump at the original 17 mL/hr rate without changing the VTBI setting. A few minutes later she stopped the pump, and the display screen showed the Rate, VTBI, and Time remaining. The nurse changed the original 0:40 h:mm Time value to 2:00 h:mm. The new Time setting was accepted. At that point the pump displayed the VTBI, Time remaining, and the option to enter Special Functions. The Rate, now recalculated to 5.63 mL/hr, was not displayed. The nurse pressed the Start button, but did not notice that the new rate now displayed at the right side of the screen, had changed from her previous setting. The infusion then ran to completion, ending 1hr 20 minutes later than expected.


Device:
Type: Pump, Infusion, Mri Compatible
Manufacturer: IRadimed Corporation
Brand: Iradimed Mridium
Model#: 3860+

Problem:
During setup for an MRI scan with anesthesia, the MRI Infusion pump - Iradimed Infusion pump with DERS (Dose Error Reduction System) in place- was programmed with the drug profile for Remifent 20 mcg/ml. During the double check process, the concentration field displayed 0.08 mcg/ml (no keying for this field occurred prior to display)-this was confirmed by a second RN and by the anesthesiologist. Attempts to key in the correct concentration were made however the field kept defaulting to 0.08mcg/ml and could not be changed despite attempts to enter correct amount. This is a locked field and should only and always display 20mcg/ml.


Device:
Type: Software, Transmission And Storage, Patient Data
Manufacturer: Zoll Medical Corporation
Brand: Zoll Data Rescunet Dispatch
Model#: Zoll Data RescuNet Dispatch
Other #: Version 4.4, Service Pack 3

Problem:
This is regarding software used in an emergency communication center by dispatchers to pinpoint correct locations for dispatch of emergency vehicles. A 911 call from an accident scene resulted in dispatch of an ambulance and helicopter to an incorrect location. The street address and city name had been entered correctly into the system which returned two identical addresses that ranked equally. The first address of the two listed was selected because both ranked 99% and both addresses in the geocoder were identical. Upon arrival to that address, an accident scene was not able to be found. It was then that the dispatcher realized the two exact addresses with the same match ranking were physically different locations. Due to erroneous map data that had been supplied from the county and the default sorting configuration of the column, the address that came up first and chosen by the dispatcher, was incorrect. As a result, the response to the scene was delayed. The patient expired at the scene, however, due to the patient's extensive injuries, it was determined the delay did not affect the outcome. A review of this identified there was a difference in intersection/range limits between the two addresses but the actual geographical location of the address was within both the intersection/range limits. The manufacturer of the software has been contacted and extensive discussions occurred regarding the functionality of the software and the integration of map overlays with their software. Since the event described above the ECC has encountered the geocoder providing an additional address with identical street information, identical 99% ranking and identical intersection/range limits but with two physically different locations. This situation did not result in any delays in patient care. Erroneous map data supplied by the county contributed to the geocoder matches.

Our concerns are:

1.Two addresses with different intersection/range limits were ranked equally.

2. The address that was the "best" match, was listed second in both situations described here.

3. Two distinct physical addresses can appear in the geocoder with exact address information, exact intersection/range limits and equal ranking.

4. The "Preview" function will show different geographic locations in these situations but is an optional field.

5. Default geocoder configuration of data was not provided to ECC staff.

6) A manufacturer published users guide for the geocoding tool has not been provided to the ECC.

Since this event, Zoll has provided the recommended geocoder configuration. The geocoder has been changed based on the recommendation. A super user of the dispatch application has been using this configuration for over three weeks. With the recommended configuration the best address for both events is ranked as the first match.


Device:
Type: System, Multipurpose, Coagulation
Manufacturer: International Technidyne
Brand: Hemochron Signature Elite

Problem:
Patient on cath table. Heparin turned off at start of procedure. MD drew blood for activated clotting time (ACT). Hemochron not working properly/malfunctioning and not permitting test to be run. Hemochron alerted that QC needed to be done (should be done periodically/automatically). Patient procedure delayed as MD waiting for ACT results to insert wire and guide for stent placement. MD forced to start Angiomax without ACT results.








































































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Updated January 1, 2013

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