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

Catalog Number UNKNOWN

Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

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 getting low flow alert.Initially, the inlet pressure was -0.01 psi, system hours was 7918 and pump hours 9202.3.The flow rate was 0lpm with the circulation pump command as 100%.Disconnected and reconnected pads using proper technique but the flow rate was 0lpm.Therapy was stopped.Arctic gel pad was emptied and disconnected then the arctic sun device placed in manual control.Fluid delivery line was in place.An inlet pressure was -7psi, the flow rate was 1.8lpm and circulation pump command as 51%.The arctic gel pad placed back one at a time and inlet pressure stabilized to 7psi.Moved pad to another port.Inlet pressure remained -0.03.When arctic gel pad removed, inlet pressure was -7psi and the flow rate was 2.1lpm.Patient was being tested for covid and nurse was unsure if arctic gel pad was back for investigation.

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 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.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.

Event Description

It was reported that the arctic sun device was getting low flow alert.Initially, the inlet pressure was -0.01 psi, system hours was 7918 and pump hours 9202.3.The flow rate was 0lpm with the circulation pump command as 100%.Disconnected and reconnected pads using proper technique but the flow rate was 0lpm.Therapy was stopped.Arctic gel pad was emptied and disconnected then the arctic sun device placed in manual control.Fluid delivery line was in place.An inlet pressure was -7psi, the flow rate was 1.8lpm and circulation pump command as 51%.The arctic gel pad placed back one at a time and inlet pressure stabilized to 7psi.Moved pad to another port.Inlet pressure remained -0.03.When arctic gel pad removed, inlet pressure was -7psi and the flow rate was 2.1lpm.Patient was being tested for covid and nurse was unsure if arctic gel pad was back for investigation.

• 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: 10345940
• MDR Text Key: 203284707
• Report Number: 1018233-2020-04851
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• 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
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1