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

Catalog Number UNKNOWN

Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964); Temperature Problem (3022)

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.The device was not returned.

Event Description

It was reported that the patient was under normothermia mode on the arctic sun device for about 59 minutes and noticed that the flow rate was 0.6 l/m.There were no alarms observed.The target temperature was 37c, the patient temperature was 35.3c and the water temperature was 40c.The rectal probe was replaced while on the phone, and correlating with the second temperature source the nurse had flipped the tubing clips around then the flow was 1.0 l/m.The nurse would call back if they had any other issues.Per follow up via nurse on 11sep2020, the nurse had trouble shooting with the ms&s, all the kinks were gone out and the flow went up.However, the nurse discontinued the normothermia mode and switched the patient to an "isolot".The nurse was unaware of what was done with the arctic gel pad.

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.The information provided by bd represents all of 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.

Event Description

It was reported that the patient was under normothermia mode on the arctic sun device for about 59 minutes and noticed that the flow rate was 0.6 l/m.There were no alarms observed.The target temperature was 37c, the patient temperature was 35.3c and the water temperature was 40c.The rectal probe was replaced while on the phone, and correlating with the second temperature source the nurse had flipped the tubing clips around then the flow was 1.0 l/m.The nurse would call back if they had any other issues.Per follow up via nurse on 11sep2020, the nurse had trouble shooting with the ms&s, all the kinks were gone out and the flow went up.However, the nurse discontinued the normothermia mode and switched the patient to an "isolot".The nurse was unaware of what was done with the arctic gel pad.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10600742
• MDR Text Key: 221775707
• Report Number: 1018233-2020-06248
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1