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

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

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.

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.

• Brand Name: ARTICGEL PADS
• Type of Device: ARCTIC 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 Key: 6571365
• MDR Text Key: 75413929
• Report Number: 1018233-2017-02431
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• 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
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 110