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

Catalog Number UNKNOWN

Device Problems Restricted Flow rate (1248); Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

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 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 there was low flow on the arctic sun device.The nurse stated they have been receiving alerts about leaks in the lines after sending patient to computed tomography.Nurse stated that they swapped out pads for a new set of pads, but they were still receiving alerts.Patient was at 34.3c, target temperature was 33c, water temperature was 7.6c, and there was no flow.Event log showed alert 001 and alert 002.Ms&s walked nurse through disconnecting and reconnecting using proper technique.All lines were straight with no kinks or bends noted.They started the therapy and device continued to flash priming and conditioning.There was no flow.The nurse placed device in manual mode at 5c.Temperature 1 was 6.3c, temperature 2 was 6.3c, temperature 3 was 27.7c, temperature 4 was 5.1c, water flow rate was 0, inlet pressure was 0, circulation pump command was 100, mixing pump command was 0, and heater was 0.System hours were 5612 and pump hours were 5112.The circulation pump appeared to have gone out.The nurse noted they have another device they could try.

Event Description

It was reported that there was low flow on the arctic sun device.The nurse stated they have been receiving alerts about leaks in the lines after sending patient to computed tomography.Nurse stated that they swapped out pads for a new set of pads, but they were still receiving alerts.Patient was at 34.3c, target temperature was 33c, water temperature was 7.6c, and there was no flow.Event log showed alert 001 and alert 002.Ms&s walked nurse through disconnecting and reconnecting using proper technique.All lines were straight with no kinks or bends noted.They started the therapy and device continued to flash priming and conditioning.There was no flow.The nurse placed device in manual mode at 5c.Temperature 1 was 6.3c, temperature 2 was 6.3c, temperature 3 was 27.7c, temperature 4 was 5.1c, water flow rate was 0, inlet pressure was 0, circulation pump command was 100, mixing pump command was 0, and heater was 0.System hours were 5612 and pump hours were 5112.The circulation pump appeared to have gone out.The nurse noted they have another device they could try.

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.Corrections: d4, d10, h3.H11:section a through f - the information provided by bd represents all of the known information at this tim.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.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10543308
• MDR Text Key: 208147948
• Report Number: 1018233-2020-05969
• 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: 01/04/2021

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: 08/26/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1