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

Catalog Number 317-09-02

Device Problems Inaccurate Flow Rate (1249); Therapeutic or Diagnostic Output Failure (3023)

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. The device was not returned.

Event Description

It was reported that the flow rate on the arctic sun device was 0. 6l/min. The patient had been maintaining normothermia for several days. The patient temperature was 37. 3c with a target temperature of 37c. The water temperature was 8. 6c, the pump hours were 3740. 3, and the system hours were 4245. 5; with pads attached, the flow rate read 0. 5l/min, the ip was -7. 3psi, and the cp was 29%. Per troubleshooting with ms&s, the nurse was instructed to empty and disconnect the pads. Manual control was enabled with the water temperature was set to 10c. Without the pads attached, the flow rate was 1. 8l/min, the ip was -7psi, and the cp was at 53%. The pads were then added back sequentially. All pads had 0-0. 2l/min flow rate and the ip was -3 to -6. 1psi. The nurse stated she would change out the device first, and if the flow rate did not rise then she would change the pads. After one hour, the nurse stated that the patient was taken off of the device for a ct scan. She obtained a new device, and called back to be instructed through setting up the new device and restarting therapy on the patient. The flow rate on the new device settled at 2. 1l/min and the patient temperature was 38. 6c. The nurse was advised that the patient temperature had risen since he was disconnected for ct scan. Ms&s explained that the water would get cold to bring the patient temperature down to target again. The nurse was advised to send the first device to biomed for evaluation.

Event Description

It was reported that the flow rate on the arctic sun device was 0. 6l/min. The patient had been maintaining normothermia for several days. The patient temperature was 37. 3c with a target temperature of 37c. The water temperature was 8. 6c, the pump hours were 3740. 3, and the system hours were 4245. 5; with pads attached, the flow rate read 0. 5l/min, the ip was -7. 3psi, and the cp was 29%. Per troubleshooting with ms&s, the nurse was instructed to empty and disconnect the pads. Manual control was enabled with the water temperature was set to 10c. Without the pads attached, the flow rate was 1. 8l/min, the ip was -7psi, and the cp was at 53%. The pads were then added back sequentially. All pads had 0-0. 2l/min flow rate and the ip was -3 to -6. 1psi. The nurse stated she would change out the device first, and if the flow rate did not rise then she would change the pads. After one hour, the nurse stated that the patient was taken off of the device for a ct scan. She obtained a new device, and called back to be instructed through setting up the new device and restarting therapy on the patient. The flow rate on the new device settled at 2. 1l/min and the patient temperature was 38. 6c. The nurse was advised that the patient temperature had risen since he was disconnected for ct scan. Ms&s explained that the water would get cold to bring the patient temperature down to target again. The nurse was advised to send the first device to biomed for evaluation.

Manufacturer Narrative

The device was not returned for evaluation. A potential failure mode could be ¿poor flow¿ with a potential root cause of ¿improper storage causing crushed pad, pad dimples, and/or pad lines¿. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use were found adequate and state the following: "5. Attach the pad¿s line connectors to the patient line manifolds. Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual). If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad. 6. Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2. 3 liters per minute, which is the minimum flow rate for a full pad kit. 7. When finished, empty water from pads. Cold temperature increases the adhesiveness of the hydrogel. For ease of removal, leave pads on the patient for approximately 15 minutes to allow the hydrogel to warm. Slowly remove pads from the patient and discard. ".

• Brand Name: ARTICGEL PADS
• Type of Device: ARCTIC SUN GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8506415
• Report Number: 1018233-2019-01913
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGCZ0256
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No