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

Catalog Number 317-05-02

Device Problems Insufficient Flow or Under Infusion (2182); Gas Leak (2946)

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 the arctic sun device showed low flow. The patient temperature was 35. 9c, target temperature was 33, water temperature 6. 9, flow rate 0. 7lpm when small pads were used. Initial inlet pressure was -3psi, system hours 838, pump hours 655. When the complainant disconnected and reconnected pads using proper technique and the fluid rate was 2. 3lpm but it dropped later and alerted low air leak ( alert 02 ) again. The therapy was stopped and the pads were disconnected or emptied. When placed in manual control, just fluid delivery line, the flow rate was 1. 8lpm, inlet pressure -7psi, circulation pump 55%. The right chest pad had a flow rate of 2. 1lpm, inlet pressure -2. 3psi and circulation pump 100. Manual control was disabled. Therapy was continued. The nurse stated that the set of pads would be changed and call if needed.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10092856
• MDR Text Key: 193701248
• Report Number: 1018233-2020-03430
• Device Sequence Number: 1
• Product Code: DWJ
• 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: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 317-05-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/21/2020
• 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