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

Device Problem Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

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 user was getting an alert 113 (reduced water temperature control) on the current arctic sun device.It was further reported that user got an alert 113 (reduced water temperature control) on another device last night.User changed arctic gel pads and sent the first arctic sun device to biomed.Currently target was 33 c, patient was at 33.6 c, water temperature was 27.6 c.Flow rate was 2 lpm, chiller temperature (t4) was 3.9 c.Mixing pump was 100%, pump hours were 4093 and system hours were 5217.Ms&s asked nurse to send device to biomed labeled as alert 113 (reduced water temperature control), not cooling and mixing pump.Per follow up via biomed on 04dec2020, confirmed they have received sn as (b)(4), and found a faulty mixing pump.It would be repaired onsite.Only one arctic sun device had been received and was unsure, which one it was from the event.The biomed would reach out to the nursing staff regarding the second device.

Event Description

It was reported that user was getting an alert 113 (reduced water temperature control) on the current arctic sun device.It was further reported that user got an alert 113 (reduced water temperature control) on another device last night.User changed arctic gel pads and sent the first arctic sun device to biomed.Currently target was 33 c, patient was at 33.6 c, water temperature was 27.6 c.Flow rate was 2 lpm, chiller temperature (t4) was 3.9 c.Mixing pump was 100%, pump hours were 4093 and system hours were 5217.Mss asked nurse to send device to biomed labeled as alert 113 (reduced water temperature control), not cooling and mixing pump.Per follow up via biomed on 04dec2020, confirmed they have received serial no as dyzcy031 and found a faulty mixing pump.It would be repaired onsite.Only one arctic sun device had been received and was unsure which one it was from the event.The biomed would reach out to the nursing staff regarding the second device.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause was not chosen due to lack of information.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review was not performed due to lack of information.H11:section a through f - 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.H3 other text : the device was not returned.

• 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
• MDR Report Key: 11069165
• MDR Text Key: 223748593
• Report Number: 1018233-2020-22021
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other