MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS

Catalog Number 317-09

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

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 the patient was cooling on the device 5755 since 2:55 pm.The nurse stated that the patient weighed (b)(6) and four large pads were in place when the patient arrived at (b)(6) hospital.The screen showed an alarm for ¿low air leak¿.The patient temperature was 36.3c, the target temperature was 33c, the water temperature was 6.5c, and the flow rate was 0.8 l/min.Per troubleshooting, the event log showed an alert 01 (patient open line) and an alert 02 (low air leak).The nurse was advised on how to disconnect and reconnect the pads using the proper technique.The flow rate was 0.2 l/min.The nurse declined troubleshooting the pads and alternatively replaced the device.It was discussed that the pads be emptied into the first device before switching to the new device.She was also advised that if there was a suboptimal flow rate displayed, it was an issue with the pads.The nurse was called back 30 min later and she reported that the issue was with the pads.She replaced the pads and the flow rate stabilized at 2.7 l/min.

Event Description

It was reported that the patient was cooling on the device 5755 since 2:55 pm.The nurse stated that the patient weighed 105 kgs and four large pads were in place when the patient arrived at memorial hospital pembroke.The screen showed an alarm for ¿low air leak¿.The patient temperature was 36.3c, the target temperature was 33c, the water temperature was 6.5c, and the flow rate was 0.8 l/min.Per troubleshooting, the event log showed an alert 01 (patient open line) and an alert 02 (low air leak).The nurse was advised on how to disconnect and reconnect the pads using the proper technique.The flow rate was 0.2 l/min.The nurse declined troubleshooting the pads and alternatively replaced the device.It was discussed that the pads be emptied into the first device before switching to the new device.She was also advised that if there was a suboptimal flow rate displayed, it was an issue with the pads.The nurse was called back 30 min later and she reported that the issue was with the pads.She replaced the pads and the flow rate stabilized at 2.7 l/min.

Manufacturer Narrative

The reported event was unconfirmed, as the product meets specifications.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 completely sealed, the connectors were found free of damages, and it was noted that there was evidence of the sealing presence on the pads.No manufacturing issues related were noted during the visual evaluation of the pads returned.Per functional evaluation, the flow rate was found to be acceptable on all the returned pads.The flow rate for this product must be above 2.4 l/min m2.No air leakage was found in any of the pads returned.The device history record was reviewed and found nothing 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.".

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTICSUN GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7434602
• MDR Text Key: 105930331
• Report Number: 1018233-2018-01221
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 317-09
• Device Lot Number: NGCN1317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 105