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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ARTICGEL PADS ARCTIC SUN GEL PADS

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C.R. BARD, INC. (COVINGTON) -1018233 ARTICGEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-09
Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)
Patient Problem Cardiac Arrest (1762)
Event Date 04/24/2017
Event Type  malfunction  
Manufacturer Narrative
Received 1 used large arcticgel pad kit without the original unit packaging. The reported event was unconfirmed. Per the visual inspection, the pads were inspected and found to have the trim pattern correctly performed, the plastic tubes were found completely assembled covering the total of clamping rings on the plastic connector and manifold connector, the foams were found free of damages, tears or perforations, the seal between manifold connector and pad was found completed sealed, the energy connectors were found free of damages, and it was noted that there was evidence of the sealing present on the pads. No manufacturing issues related were noted during the visual evaluation of the pad returned. During the functional evaluation, the pads were submitted to the flow rate test with the arctic sun machine model 2000. The pads were connected to the arctic sun machine model 2000 for 10 minutes, see details below: right chest pad: a total of 2. 43 l/min m2 of flow rate were registered during the test. Left chest pad: a total of 2. 92 l/min m2 of flow rate were registered during the test. Right thigh pad: a total of 3. 82 l/min m2 of flow rate were registered during the test. Left thigh pad: a total of 3. 34 l/min m2 of flow rate were registered during the test. According to the test method, the flow rate was found to be acceptable on all of the returned pads. The flow rate for this product must be above 2. 4 l/min m2. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: ¿6. Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2. 3 liters per minute, which is the minimum flow rate for a fullpad kit. ¿ (b)(4).
 
Event Description
It was reported that the pads gave low flow. The patient experienced cardiac arrest (sca) in the icu, and therefore received hypothermia therapy. The pads were tested with two different arctic sun machines, and the pads did not work. It was later reported that therapy was discontinued as a result of the low flow alert.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the pads gave low flow. The patient experienced cardiac arrest (sca) in the icu, and therefore received hypothermia therapy. The pads were tested with two different arctic sun machines, and the pads did not work. It was later reported that therapy was discontinued as a result of the low flow alert.
 
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Brand NameARTICGEL PADS
Type of DeviceARCTIC SUN GEL PADS
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6571365
MDR Text Key255111630
Report Number1018233-2017-02431
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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