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

Catalog Number UNKNOWN

Device Problems Insufficient Cooling (1130); Insufficient Flow or Under Infusion (2182); Gas/Air Leak (2946)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was not cooling on the arctic sun device.The target temperature was 98.6f (37c), the patient temperature was 99.4f (37.5c), the water temperature was 42f (5.6c), the flow rate was 1.2l/min.The arctic sun device was displaying 'low air leak' and an alert 02 (low flow) intermittently.System diagnostics showed flow rate was 1.2l/min, the inlet pressure was -7 and the circulation pump command was 48%.Ms&s had nurse check the arctic gel pad tubing for bends or kinks and emptied and disconnected the arctic gel pads.They enabled manual control and set water to 10c.With no arctic gel pads attached, flow rate was 1.8l/min, the inlet pressure was -6.8 and the circulation pump command was 68%.They added back arctic gel pads sequentially and the results were as followed.With left thigh pad added, the flow rate was 0.7l/min, the inlet pressure was -7.2 and the circulation pump was 40%.With right thigh pad added, the flow rate was 1.1l/min, the inlet pressure was -7.3 and the circulation pump command was 47%.With right chest pad added, the flow rate was 1.8l/min, the inlet pressure was -7.1 and the circulation pump command was 61.With left chest pad added, the flow rate was 2.5l/min, the inlet pressure was -7.1 and the circulation pump command was 61%.They disabled manual and restarted therapy, the flow rate settled at 1.9l/min and the patient was shivering.Bair hugger was in place for counter warming.The nurse stated they would give shivering medication.Ms&s acceptable flow rates.

Event Description

It was reported that the patient was not cooling on the arctic sun device.The target temperature was 98.6f (37c), the patient temperature was 99.4f (37.5c), the water temperature was 42f (5.6c), the flow rate was 1.2l/min.The arctic sun device was displaying 'low air leak' and an alert 02 (low flow) intermittently.System diagnostics showed flow rate was 1.2l/min, the inlet pressure was -7 and the circulation pump command was 48%.Ms&s asked nurse to check the arctic gel pad tubing for bends or kinks and emptied and disconnected the arctic gel pads.They enabled manual control and set water to 10c.With no arctic gel pads attached, flow rate was 1.8l/min, the inlet pressure was -6.8 and the circulation pump command was 68%.When added back arctic gel pads sequentially and the results were as followed.With left thigh pad added, the flow rate was 0.7l/min, the inlet pressure was -7.2 and the circulation pump was 40%.With right thigh pad added, the flow rate was 1.1l/min, the inlet pressure was -7.3 and the circulation pump command was 47%.With right chest pad added, the flow rate was 1.8l/min, the inlet pressure was -7.1 and the circulation pump command was 61.With left chest pad added, the flow rate was 2.5l/min, the inlet pressure was -7.1 and the circulation pump command was 61%.They disabled manual and restarted therapy, the flow rate settled at 1.9l/min and the patient was shivering.Bair hugger was in place for counter warming.The nurse stated they would give shivering medication.Ms&s acceptable flow rates.Per follow up via nurse on (b)(6) 2020, after trouble shooting with ms&s the issue was resolved.Therapy was completed on the same device and pads.The pads were disposed of and the device was kept in service.Nurse could not recall the medication they stated the would administer.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be, "user cuts or punctures pads or pad lines." the lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the arctic gel pad product ifus were found to be adequate based on past reviews.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10588539
• MDR Text Key: 222822187
• Report Number: 1018233-2020-06217
• 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: 01/21/2021

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1