MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS; ARCTIC GEL PADS

Catalog Number 317-07-02

Device Problems Disconnection (1171); Connection Problem (2900); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

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 during on going therapy no flow built up.There was no connection under the insulation.Subsequently, the pads were exchanged, and the arctic sun worked.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: mfr site.

Event Description

It was reported that during on going therapy no flow built up.There was no connection under the insulation.Subsequently, the pads were exchanged, and the arctic sun worked.

Event Description

It was reported that during on going therapy no flow built up.There was no connection under the insulation.Subsequently, the pads were exchanged, and the arctic sun worked.

Manufacturer Narrative

Received 1 used articgel pad kit for evaluation.The reported event was confirmed.During visual inspection, it was noted that one of the connectors was disconnected from the tubing in the left leg pad.Dimensional evaluation showed that the tube was found out of specification.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use state the following: "5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.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 full pad kit." correction: concomitant medical products.

• Brand Name: ARCTICGEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7403442
• MDR Text Key: 104907201
• Report Number: 1018233-2018-01066
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 317-07-02
• Device Lot Number: NGBY1695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 06/08/2018; 06/22/2018
• Supplement Dates FDA Received: 06/14/2018; 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1