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

Catalog Number UNKNOWN

Device Problems Inaccurate Flow Rate (1249); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration in Body Temperature (4568)

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 arctic sun device was receiving an alert 01 (patient line open) and no flow when patient was undergoing normo thermia therapy for the last day.The nurse did troubleshooting and changed out the arctic gel pads but the still received a same alerts.Currently, the arctic sun device had no flow even though the therapy initiated.The patient temperature was 40c and the target temperature was 37c.The nurse had place the arctic sun device in manual mode at 5c and ran the device, the outlet monitor temperature (t1) was 16c, the outlet control temperature (t2) was 15.9c, the inlet temperature was 19.7c, the chiller temperature (t4) was 13.4c, the water flow rate was 3 i/m, the inlet pressure was -7.3 psi, the circulation pump command was 74%, the mixing pump command as 100%, the system hours was 6872.1 and the pumping hours was 5815.8.Disabled manual mode and started therapy after about 5 minutes then the water flow rate was 2.8 l/m, the inlet pressure was -7.5 psi and the circulation pump command was 73%.And there were no alerts.Advised to send down to biomed after therapy for pumps to be evaluated based on system and pump hours.

Event Description

It was reported that the arctic sun device was receiving an alert 01 (patient line open) and no flow when patient was undergoing normo thermia therapy for the last day.The nurse did troubleshooting and changed out the arctic gel pads but the still received a same alerts.Currently, the arctic sun device had no flow even though the therapy initiated.The patient temperature was 40c and the target temperature was 37c.The nurse had place the arctic sun device in manual mode at 5c and ran the device, the outlet monitor temperature (t1) was 16c, the outlet control temperature (t2) was 15.9c, the inlet temperature was 19.7c, the chiller temperature (t4) was 13.4c, the water flow rate was 3 i/m, the inlet pressure was -7.3 psi, the circulation pump command was 74%, the mixing pump command as 100%, the system hours was 6872.1 and the pumping hours was 5815.8.Disabled manual mode and started therapy after about 5 minutes then the water flow rate was 2.8 l/m, the inlet pressure was -7.5 psi and the circulation pump command was 73%.And there were no alerts.Advised to send down to biomed after therapy for pumps to be evaluated based on system and pump hours.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section." the lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the arctic gel pads product ifus were found to be adequate based on past reviews.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• 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: 10553061
• MDR Text Key: 208741405
• Report Number: 1018233-2020-06029
• 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: 01/08/2021

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: 08/28/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 12/20/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1