MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS; UNKNOWN ARCTICGEL PAD

Catalog Number UNKNOWN

Device Problems Restricted Flow rate (1248); Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954)

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 was changed out because the patient's temperature remained at 36.9c.The second device (serial number (b)(4)) displayed a low flow alert and the flow rate was 0 l/m.There were 5 pads in use.The nurse reconnected and disconnected the pads using proper technique and there was no change in flow rate.The nurse took off the fluid delivery line then the flow rate was 2.2 l/m and the inlet pressure was at the range of -10 psi with the circulation pump command as 50.The nurse disconnected each pad one by one using the proper technique and the flow dropped with the right trunk pad.The flow increased but not to an optimal level when this pad was disconnected.It was recommended to switch back to the first device to check whether the flow rate was better with the first device.The patient remained on the second device where the flow rate was 1.6lpm as the hospital does not have a second set of pads.The patient was able to still reach the target temperature.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section."" he lot number is unknown; therefore, a device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.

Event Description

It was reported that the arctic sun device was changed out because the patient's temperature remained at 36.9c.The second device (serial number 5056) displayed a low flow alert and the flow rate was 0 l/m.There were 5 pads in use.The nurse reconnected and disconnected the pads using proper technique and there was no change in flow rate.The nurse took off the fluid delivery line then the flow rate was 2.2 l/m and the inlet pressure was at the range of -10 psi with the circulation pump command as 50.The nurse disconnected each pad one by one using the proper technique and the flow dropped with the right trunk pad.The flow increased but not to an optimal level when this pad was disconnected.It was recommended to switch back to the first device to check whether the flow rate was better with the first device.The patient remained on the second device where the flow rate was 1.6lpm as the hospital does not have a second set of pads.The patient was able to still reach the target temperature.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTICGEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10151348
• MDR Text Key: 195396558
• Report Number: 1018233-2020-03795
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2020
• 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
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1