Highlighted Reports
MedSun: Newsletter #52, September 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 June 1 through June 30 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.


CARDIOVASCULAR

Device:
Type: Hemodynamic Monitor System
Manufacturer: McKesson Information Solutions LLC, McKesson Israel LTD
Brand: Horizon Cardiology
Cat #: CE-TCSHEM003

Problem:
Patient was brought to cath lab for emergent temporary pacemaker. Monitor technician initiated the Horizon cardiology program for monitoring the patient and documenting the case. System failed to initialize. An error message appeared "Internal". IS was contacted, but they were unable to resolve issue. McKesson support was also contacted for assistance. Situation not resolved until case completed. All documentation and vital signs done manually. No harm to the patient.


Device:
Type: Kit, Catheter, Intra-aortic Balloon
Manufacturer: Arrow Internation
Brand: Fiberoptix
Model#: IAB-05840-LWS
Lot #: MF0042502
Cat #: IAB-05840-LWS

Problem:
Patient needed an intra-aortic balloon. The balloon was then prepped and inserted into the femoral artery through the provided arterial sheath with a side arm. The balloon had a lot of resistance going through the provided sheath. The physician attempted to remove the balloon from the sheath, but the balloon had been damaged beyond use. The balloon was unable to be removed from the sheath, so the balloon catheter was removed along with the sheath. A second balloon was prepped. The package comes with two different sheaths and the other sheath with no side arm was used for balloon placement without any further complications. The patient had no apparent injury.

Manufacturer provided RGA# for product return evaluation and provided shipping container.


Device:
Type: Monitor System, Telemetry
Manufacturer: GE Healthcare
Brand: Apexpro
Other #: Software 5.1

Problem:
Patient had a 12 beat run of Vtach which did not alarm on the monitoring system. The event was observed by the Cardiac Arrhythmia Technician. The physician was notified, labs drawn, and treatment administered as ordered without further incident.

Manufacturer response: GE is responsive and analyzing strips. Conference call planned.


Device:
Type: System, Thermal Regulating
Manufacturer: Cincinnati SubZero
Brand: Blanketrol Ii

Lollipop Icon

Problem:
Infant in NICU receiving hypothermia therapy to minimize brain injury. Infant noted to have a core temperature of less than the expected 33.5°C. Infant was assessed. Cooling blanket was assessed and found to be set at "5°C Manual." It had not been switched to "33.5°C Automatic." Infant's core temperature dropped to 30°C. She was re-warmed after blanket was reset to "33.5°C Automatic." Infant's heart rate decreased to 69 bpm, no dysrhythmias were noted.

While reviewing instruction manual for setup instructions, it was noted that the need to switch from "5°C Manual" to "33.5° C Automatic" was not written clearly.


Device:
Type: Lead, Defibrillation
Manufacturer: Medtronic, Inc.
Brand: Sprint Fidelis
Model #: 6949-65cm

Problem:
The patient called the office stating that his ICD was beeping, advised patient to send in a Carelink transmission which showed noise on the RV lead indicating a possible fracture of the lead. The patient was then advised to come into the office. The patient was scheduled for an explant two days later. The lead was explanted and a new lead implanted. The patient did really well.
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Health Professional's Impression
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The fracture in the lead caused the ICD device to think pt was having or have had some ventricular arrhythimas leading to a possible shock from the device.

Comment from FDA: Physician practices are now partnering with the MedSun program. This report was received from a physician's practice.


Device 1:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1003254
Cat #: 1741-003

Device 2:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1003114
Cat #: 1741-003

Device 3:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 0912234
Cat #: 1741-003

Device 4:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1004134
Cat #: 1741-003

Device 5:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1005034
Cat #: 1741-003

Device 6:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1003294
Cat #: 1741-003

Device 7:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 1003024
Cat #: 1741-003

Device 8:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 0908140
Cat #: 1741-003

Device 9:
Type: Electrode, Electrocardiograph, Pediatric
Manufacturer: ConMed Corporation
Brand: Neotrode Ii
Lot #: 0908104
Cat #: 1741-003

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Problem:
Some of ConMed Neotrode II neonatal/Pediatric ECG Electrodes have failed out of the packaging. Over a month period our facility has reported 36 failures on 9 different lot numbers and manufacturing dates. The staff are reporting poor ECG signals or no signal and lots of artifact. The problem was identified by doing an x-ray of some of the electrodes and our Clinical Engineering staff using their meters to perform continuity tests. Defective electrodes can't be identified visually. Failure point of the electrode is where the patch is connected to wire, a failure to bond or weld correctly. In talking to ConMed about this problem, they informed us they have researched this problem and have determined that the failure is due to a malfunction of a machine that assembles these electrodes. We were informed the machine was repaired and is functioning properly. Product manufactured before 05/03/2010 could be problematic, which is consistent with our findings of multiple lot number and manufacturer dates. The manufacturer is in process of replacing problematic product. The affected product was returned to ConMed. All product was returned and all lot numbers. Our facility has return a total of 13 unopened cases, and around 7 open cases of product that was pulled back from departments when new product was delivered here at our facility. ConMed is process of replacing all stock at all 9 hospitals in our corporation.
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Health Professional's Impression
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Multiple failures, lots of frustration from staff, before finding product that would work correctly. Sometime opening six packages before find a good set of ECG lead wires.
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Manufacturer response for Neonatal / Pediatric ECG Electrode Set, Neotrode II
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Conmed has investigated the recent situation (based on recent complaints) and has determined that there is no reason (from a quality /safety perspective) to have product returned from the field. The situation appears to be intermittent and infrequent (with no risk to the patient and or/ clinicians). We have performed all of the necessary steps to ensure that we are providing the most appropriate response (in regards to federal requirements and regulations). As a proactive step to ensure performance of our products, we implemented additional tests and inspections throughout the manufacturing process (implemented in early May).


CLINICAL CHEMISTRY

Device:
Type: Calculator/data Processing Module, For Clinical Use;
Manufacturer: Cerner
Brand: Bridge Specimen Collection System
Other #: Zebra label printer

Problem:
Specimen label from the Bridge Specimen Collection System printed label with Patient A and CPI, but with a bar coded accession number and test that belonged to a previously printed Patient B. The laboratory automation line caught and rejected the erroneous specimen label and no erroneous results were reported on the either patient.
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Manufacturer response for Cerner's Bridge Specimen Collection system:
Cerner suggested a patch that "cleans up" label files when ever the application is "abruptly interrupted", such as loss of wireless connectivity, etc. They believe this will prevent the "incomplete label record" from "Patient A" from ever being available for "Patient B". We moved that code into production; no new incidents have been reported.


GENERAL & PLASTIC SURGERY

Device:
Type: Bipolar Forceps
Manufacturer: Ascent
Brand: Pks Cutting Forceps
Model#: 920005PK
Lot #: 1063059
Other #: 5 mm diameter

Problem:
A reprocessed Ascent handpiece did not function as the doctor expected it to when engaged. The device was expected to cauterize and then cut, but it did not cut. The device was sent to Ascent, the reprocessor, and they found fault with the handling of this device and they are correcting their process. All similar product was returned to Ascent.
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Health Professional's Impression
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If it did not cauterize and then cut, there would be potential blood loss and delay of surgery for device replacement.


Device:
Type: Newborn Heel Incision Device
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Brand: Tenderfoot
Lot #: BB062
Other #: 1.0mm length 2.5mm

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Problem:
The nurse was performing a heel stick on an infant. She opened the Tenderfoot device and removed the safety lock. The infant's heel had been prepped. The RN placed the device on the heel and activated it by pushing the slide bar. Normally, the device would auto-lance the infant's heel. However, in this instance, the device split open and the lancing device came out of the side instead of at the opening in the bottom of the device. The infant and RN were not hurt. However, had the RN been holding the device in a different way, the RN could have been cut by the lancet. The RN obtained another device and drew the infant's blood. The RN's on the unit have not had this experience with this type of device before. All are experienced users. Prior to using the device, there was no indication that the device would fail or was faulty in any way. No unusual or excessive force/pressure was applied to the device.
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Health Professional's Impression
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Staff does not know why the device failed or what could have caused it to do so.
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Manufacturer response for Tenderfoot Heel Incision Device
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We are awaiting instructions to return the device to the manufacturer for their investigation and analysis.


Device:
Type: System, Ablation, Microwave
Manufacturer: Medwaves
Brand: Medwaves Microwave Generator
Model#: MWG881

Problem:
During a tumor ablation, the microwave antenna treatment delivered a lower energy than what was displayed on screen. Patient was not harmed but required a repeat treatment.


GENERAL HOSPITAL

Device:
Type: Catheter, Implanted, Port
Manufacturer: AngioDynamics
Brand: Vortex Mp Port
Model#: Vortex MP-P5SAT
Lot #: 504544

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Problem:
During the procedure to implant Vortex MP Port (size 5 French) in the chest, and with very little manipulation of the catheter, the catheter broke off at the junction of the metal lock. The rest of the catheter completely separated. This is the second time within the last couple of months that we have seen this kind of failure. In this case, the catheter was pre-attached. The catheter broke, and upon inspection the catheter was very brittle, and easy to break with very little force. The risk is if it went undetected and/or broke off after implant, then it could cause catheter embolization.


Device:
Type: Catheter, Picc
Manufacturer: Becton Dickinson
Brand: Bd 2. 6French
Model#: unk
Lot #: 7114730, 9113195, 9063169,
Cat #: 384466
Other #: lot number 9063769

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Problem:
A 2.6 French dual lumen BD catheter was placed. Eight days later the catheter was noted to have leakage from the blue port at the bifurcation, but then stopped. Two days later at noontime, the blue port again was noted to be leaking at the bifurcation. The infant was also noted to be febrile and had an elevated white count. After extensive team discussion, the decision was made to clamp off the blue port and use as a single lumen. Later on that day at 1600, the red port was noted to be leaking. A decision was made to remove line. Patient currently has a single lumen broviac used for parental nutrition/intralipids, dopamine, opioid infusion, and has an 8 French left internal jugular hemodialysis catheter. Additional access was required for triple antimicrobial coverage and sedation. After eight attempts, a peripheral IV was placed in the right foot. There have been recent incidences of leaking of BD dual lumen catheters elsewhere in the hospital over the past few months for which a practice alert had been sent. At that time NICU CNS checked all lot numbers in unit and confirmed lot numbers were not included in those reported as defective. A decision was made not to remove given that there was no available replacement of appropriate size.

Remove BD dual lumen catheters from NICU supply, both 2.6 and 3.5 French. Continue search for appropriate alternative product. Discuss at NICU meeting.

See device image:
2.6 French dual lumen BD catheter experienced leakage from the blue port at the bifurcation.  This image shows where leaking occurred.


Device:
Type: Catheter, Picc, Stylet
Manufacturer: Bard Access Systems, Inc
Brand: 5Fr Powerpicc With Sherlock Tip Location System (Tls) Stylet
Lot #: REUA1183

Problem:
A female patient was admitted with respiratory and cardiac issues. A PICC (peripherally inserted central line) was inserted, and a routine post insertion chest film revealed what appeared to be a 6 cm wire fragment in her axilla vein. The wire fragment is presumed to be from the tip of the stylet wire used to insert the catheter. An interventional radiologist physician removed the wire fragment without difficulty.


Device 1:
Type: Bed, Ac-powered
Manufacturer: KCI USA, Inc.
Brand: Barimaxx Ii Bed With Maxxair Ets Mattress Replacement

Device 2:
Type: Mattress, Air Flotation
Manufacturer: KCI USA, Inc.
Brand: Maxxair Ets Mattress

Problem:
We have had 2 safety events of airway compromise related to the use of the KCI BariMaxx II bed with the MaxxAir ETS Mattress Replacement System. The mattress is not supported by a battery back up and when the bed was unplugged for transport the mattress deflated causing a shift in the patient's position in bed. This shift in patient position resulted in mechanical compromise of the airway.
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Health Professional's Impression
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The lack of a battery back up to maintain mattress inflation resulted in deflation of the mattress to the 3 inch foam surface below, causing a shift in position resulting in airway compromise.


Device 1:
Type: Software, Documentation And Charting
Manufacturer: McKesson Information Solutions, LLC
Brand: Horizon Clinicals
Other #: Horizon Clinicals Version 10.1.1.2 with HED Version .225

Device 2:
Type: Physiological Monitor, Database Server
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: M3154
Cat #: Software Version, K.00.27
Other #: Other servers running versions E.01.26 to K.00.27 - all with same problem

Problem:
This event is not patient specific, rather it is a software interaction problem involving Philips Intelliview Patient Monitor System and McKesson Horizon Clinical Charting System. Issue is that readings of NIBP do not always chart the correct NIPB value when the Horizon Clinical application is set to filter or chart the value every 15, 30, 60, etc. minutes.

Our problem is that the NIBP value that shows up in McKesson Horizon Clinicals is the value from a measurement taken 15 minutes earlier.

Example: Clinician starts an NIBP reading after setting the Philips Intelleview Monitor (in this case an MP70) to take an NIBP measurement every 15 minutes. The Clinician pushing the NIBP start button at 11:55. The Intelliview monitor starts the inflation of the cuff, then starts deflating, then displays the value. The time now is 11:57. At 12:00 McKesson Horizon Clinicals performs a query and receives the NIBP value. Everything is good, values are correct.

The problem now starts. The Philips Intelliview monitor will, over time, round up the NIBP start time to the quarter hour (this is a built in feature of the software the user cannot disable). So for example, an hour later, instead of the NIBP starting at say 12:55, it will now start the NIBP measurement at 1:00. Also at 1:00, McKesson Horizon Clinicals is set to querying for NIBP data from Philips which at this exact point in time has not completed the NIBP measurement and thus still has the value from the 12:45 NIBP measurement. The NIBP measurement starts at the quarter hour but does not have a value until the measurement has completed which might take anywhere from 45 seconds to 3 minutes depending on if the monitor has to retry 2 or 3 times, etc.

In critical care areas patients are monitored closely for the efficacy of medication administration, especially vasoactive drugs. A delayed reading of blood pressure could lead the bedside nurse to adjust the dosage of medication incorrectly, leading to possible serious injury or even death.

Our Biomed dept is unable to find a solution to the DAS problem working with either manufacturer, Philips and McKesson. The following is from an e-mail communication with Philips Support:
Customer has concerns about the way Philips system sends NIBP data via HL7 to McKesson charting system.

He has a large server network with 5 DBS and 1 Patient Link with MPx monitors. The MPx monitors are configured for auto NIBP measurements every 15 minutes. The McKesson system queries the DBS or PL once every minute, however it applies a filter to the NIBP data so that the nurses view it on the charting system only in 15 minute intervals.

The problem is the MPx monitor starts the NIBP clock when the pump starts, but it may sometimes take a minute or two to actually get a reading (due to patient-related or application issues). During that time McKesson would have queried for the data and received it but may not be able to display in the nurses 15 minute view because of that 1-2 minute lag.

As a workaround, the customer has disabled the external time source at the master DBS and has manually offset the time 1-2 minutes ahead at the master DBS to compensate for the time discrepancy of the NIBP measurements.

The customer is suggesting that the MPx monitor be modified so that once it detects an active HL7 connection, it should start the NIBP pump 1-2 minutes earlier so that the data is not missed on the display view at the McKesson charting system.

The customer has also received feedback from customer support at other non-Philips sites that (another) vendor's monitors do not have this problem because they allow you to offset the NIBP start time a little bit.



Device:
Type: Thermometer Probe Covers
Manufacturer: Welch Allyn, Inc.
Brand: Welch Allyn Probe Covers
Lot #: 0107 6
Cat #: 05031
Other #: 706486-C

Problem:
The RN noticed that the individual box of thermometer probe covers do not indicate whether or not there is latex present in the product. If preparing a room for a patient with a latex allergy, the staff would not know if the covers had latex in them unless they called Central Stores. The large container that the boxes are delivered in indicates that there is no latex in the product, but the end user has no way of knowing this from the information that is printed on the individual containers. This was brought to the attention of the manufacturer. Staff suggest that a label indicating 'no latex' or 'latex free' be printed on the individual probe cover boxes.
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Health Professional's Impression
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the manufacturer only prints 'latex free' on the large shipping box, not on each individual product box.
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Manufacturer response for thermometer probe covers, Welch Allyn probe covers
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We recommended to the manufacturer that they consider labeling each individual box with the phrase 'latex free'.


HEMATOLOGY


Device 1:
Type: Analyzer, Chemistry
Manufacturer: ITC
Brand: Hemochron Signature Elite
Model#: Signature Elite

Device 2:
Type: Analyzer, Chemistry
Manufacturer: ITC
Brand: Hemochron Signature Elite
Model#: Signature Elite

Device 3:
Type: Analyzer, Chemistry
Manufacturer: ITC
Brand: Hemochron Signature Elite

Problem:
Test is used to determine clotting time prior to, during, and immediately after cardiac bypass. Test is also used during carotid vascular surgery. It measures clotting time to help clinicians know how much heparin to give pt's to prevent clotting while blood flow is stopped or impeded by surgery. Clinicians have been getting widely variant results. When immediately repeated, results significantly different. At times, result is higher after no heparin, and at times, result does not increase with heparin as it should. Staff have been running two machines side by side and/or performed tests more frequently to try to treat the patient, but are unsure of the accuracy of their results. Staff has experienced problems since March. The problem was recently brought to attention of Risk Mgt. The manufacturer is aware and has already come in to observe practice. The mfr made recommendations for change in practice with anesthetists to align with what perfusionists were doing. Staff still experiencing variant results after adjusting testing procedure. The company has taken one of three machines back for evaluation, and provided one loaner. Of the remaining two machines that remain in house the staff has experienced variant results on both machines. They do not record the serial # of the machine, so detailed incidents can not be attributed to each specific machine. Details of several incidents are being faxed to provide examples of what is happening.
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Manufacturer response for Coagulation System, Hemochron Signature Elite
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They have not yet come to observe what happens during a case to see what is happening.
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Manufacturer response for Coagulation system, Hemochron Signature Elite


MICROBIOLOGY

Device:
Type: Wound Culture Swab & Medium
Manufacturer: Remel
Brand: Bactiswab
Lot #: 862518
Cat #: 12100

Problem:
As the nurse crushed the culture medium vial, a sharp object came through the plastic tube that caused the nurse to cut his finger.


NEUROLOGY

Device 1:
Type: Agent, Injectable, Embolic
Manufacturer: Micro Therapeutics, Inc. Dba Ev3 Neurovascular
Brand: Onyx 18
Lot #: 8333559

Device 2:
Type: Catheter, Continuous Flush
Manufacturer: Micro Therapeutics, Inc. Dba Ev3 Neurovascular
Brand: Marathon
Lot #: 7489723
Other #: Microdelivery Marathon catheter,1.5F/013 inchX165 cmX25cm

Problem:
During Arterio-Venous Malformation (AVM) procedure, a microcatheter was used and Onyx 18 was injected in to the AVM. Upon attempt to remove the catheter, the Onyx adhered to the microcatheter and a piece of the microcatheter had to be broken off to get the catheter out. Approximately 12cm of the catheter was retained in the patient. It is estimated that the amount of Onyx reflux was approximately 1cm. Vasospasm is not thought to have contributed to the event. The patient experienced no complications in the immediate post procedure period, but on the following morning, did experience a syncopal event during ambulation. The patient then underwent infusion of thrombolytics, CT scan showed a possible right posterior intracerebral (IC) cerebrovascular accident (CVA). By the second day, post procedure, the patient had recovered full strength and was discharged home several days later. There are no plans to have the retained catheter surgically excised.


OPHTHALMIC

Device:
Type: Occular Cannula And Plug
Manufacturer: Alcon Research, LTD
Brand: Alcon Total Plus 23ga Vvtrectomy Pak
Lot #: 9023848X-2009-07
Cat #: 8065750828

Problem:
The patient was undergoing eye surgery. Normally during this kind of case, cannulas are inserted into the eye and are capped with plugs to maintain gas inflation of the eye. In this case, the plugs did not fit in the cannulas--they were too big. This is unusual, particularly since the cannulas and plugs all come together in one kit. The patient was not harmed by this event; however, the physician was quite frustrated. None of the staff involved in the event have ever had this experience before. Another kit from the same manufacturer and reference number was obtained and used for the case. The kit which contained plugs that did not fit the cannulas was saved and the rep was contacted. OR staff are coordinating the return of the device to the manufacturer.
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Health Professional's Impression
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The physician and staff believe that either the wrong size plugs or wrong size cannulas were placed into the same kit.
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Manufacturer response for occular cannula and plug, Alcon Total Plus 23ga vitrectomy pak
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OR staff called the rep on the day of the event. No further follow up has been received as of the filing of this report.


PHYSICAL MEDICINE

Device:

Type: Warm Pack
Manufacturer: Hospital Marketing Services, Co., Inc
Brand: Novation
Model#: V6001-047
Lot #: 7981-3

Problem:
The nurse was attempting to activate a heat pack for her patient. She squeezed the bag to pop the inner chamber and get the pack warming. However, the heat pack didn't warm up. She tried three--all with the same result. On the fourth try, she had one that did get warm. All four packs were from the same manufacturer, model and lot numbers. All of the heat packs are stored in the same area. We have seen this problem before. In the past, the manufacturer found a pin-hole size opening in the inner pouch. Staff suspect that this may be the cause for these packs not heating up.

We are awaiting the manufacturer's response. We will return the device to them for their investigation/analysis.


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Lollipop Icon Special Note:
The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.


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