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

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 there was low flow on the arctic sun device.The event log displayed alert 07, alert 02 (wo-00027484) and alert 1113.The stated that the water temperature was too cold.The nurse stated the rewarm rate was set to 0.1c/hour and the current water temperature was 9c.The device was placed in manual control at 40c and the water temp was increased to 40c without any issue.However, when they disabled manual control and restarted therapy they got alert 02.Inlet pressure(ip) was 3.4psi, system hours were 6671.1 and pump hours were 5881.The nurse disconnected and reconnected pads using proper technique.Ip was -4.9psi, flow rate (fr) was 0lpm, and the circulation pump (cp) was 100%.They have no other machines available (states all are giving low flow issues).They stopped therapy, emptied/disconnected pads and placed the device in manual control again.Just with the fluid delivery line attached: ip was -7psi, fr was 1.8lpm and cp was 29%.They added the right chest pad: ip was -6.8psi, fr was 2lpm, and cp was 53%.The added left chest pad: ip was -7.1psi, fr was 1.9lpm, and cp was 52%.The nurse connected both thigh pads at the same time: ip was -7psi, fr was 1.9lpm, and was cp 54%.They stopped/disabled manual control and restarted rewarm again.Fr was initially 1.9lpm, but the fr dropped to zero after a few minutes.Ms&s explained the biomed has three devices in his area.We can try testing them to see if one of them work.

Event Description

It was reported that there was low flow on the arctic sun device.The event log displayed alert 07, alert 02 and alert 113.The nurse stated that the water temperature was too cold.The nurse stated the rewarm rate was set to 0.1c/hour and the current water temperature was 9c.The device was placed in manual control at 40c and the water temp was increased to 40c without any issue.However, when they disabled manual control and restarted therapy they got alert 02.Inlet pressure(ip) was 3.4psi, system hours were 6671.1 and pump hours were 5881.The nurse disconnected and reconnected pads using proper technique.Ip was -4.9psi, flow rate (fr) was 0lpm, and the circulation pump (cp) was 100%.They have no other machines available (states all were giving low flow issues).They stopped therapy, emptied/disconnected pads and placed the device in manual control again.Just with the fluid delivery line attached: ip was -7psi, fr was 1.8lpm and cp was 29%.They added the right chest pad: ip was -6.8psi, fr was 2lpm, and cp was 53%.The added left chest pad: ip was -7.1psi, fr was 1.9lpm, and cp was 52%.The nurse connected both thigh pads at the same time: ip was -7psi, fr was 1.9lpm, and was cp 54%.They stopped/disabled manual control and restarted rewarm again.Fr was initially 1.9lpm, but the fr dropped to zero after a few minutes.Ms&s explained that the biomed has three devices in his area testing them to see if one of them would work.

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.

• Brand Name: ARCTIC GEL PADS
• Type of Device: UNKNOWN ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10155495
• MDR Text Key: 195717927
• Report Number: 1018233-2020-03859
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1