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

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that nurse starting therapy and getting alert 01 (patient line open) on the arctic sun device.The initial values flow rate was 0lpm, circulation pump command was 0 percentage (pr# 7305564).Nurse disconnected and reconnected arctic gel pads using proper technique and there were same results.Nurse was able to get another device with serial number dyfpal032.Nurse connected pads to new device.The device continues to have flow rate issue after confirming proper connection.Nurse stopped therapy and disconnected pads and enabled manual control.The inlet pressure was -7.1psi, circulation pump command was 48 percentage and flow rate were 1.7lpm.Nurse added right chest pad the inlet pressure was -7.1psi then added left chest pads the inlet pressure dropped to 3-.8psi (pr# 7311104).Nurse removed left chest and added right thigh the inlet pressure was -7.2psi and added left thigh pad the inlet pressure was -7.2psi, flow rate was 1.5lpm (pr# 7313417) and circulation pump command was 45 percentage.Mis recommended to nurse to swap out the left chest pad for a universal or two if needed for coverage and to save this chest pad for investigation.The flow rate should increase with the addition of the universal pad.Per follow up information received via phone on (b)(6) 2023, it was reported that there was no impact to the 55-year-old, male patient and therapy was completed.Nurse was advised by mis to change the pads.The device works without any alarms and it was not sent to biomed.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned.A potential root cause for this failure could be "belt temperatures too low after nip roller and heated section".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be completed due to no lot number provided.The product catalog number and lot number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that nurse starting therapy and getting alert 01 (patient line open) on the arctic sun device.The initial values flow rate was 0lpm, circulation pump command was 0 percentage (b)(4).Nurse disconnected and reconnected arctic gel pads using proper technique and there were same results.Nurse was able to get another device with serial number: (b)(6).Nurse connected pads to new device.The device continues to have flow rate issue after confirming proper connection.Nurse stopped therapy and disconnected pads and enabled manual control.The inlet pressure was -7.1psi, circulation pump command was 48 percentage and flow rate were 1.7lpm.Nurse added right chest pad the inlet pressure was -7.1psi then added left chest pads the inlet pressure dropped to 3-.8psi (b)(4).Nurse removed left chest and added right thigh the inlet pressure was -7.2psi and added left thigh pad the inlet pressure was -7.2psi, flow rate was 1.5lpm (b)(4) and circulation pump command was 45 percentage.Mis recommended to nurse to swap out the left chest pad for a universal or two if needed for coverage and to save this chest pad for investigation.The flow rate should increase with the addition of the universal pad.Per follow up information received via phone on 10mar2023, it was reported that there was no impact to the 55-year-old, male patient and therapy was completed.Nurse was advised by mis to change the pads.The device works without any alarms and it was not sent to biomed.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16581863
• MDR Text Key: 312261114
• Report Number: 1018233-2023-01885
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male