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

Catalog Number UNKNOWN

Device Problems Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954); Therapeutic or Diagnostic Output Failure (3023)

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 there was low flow on the arctic sun device.The device was maintaining patient temperature at 34c.Now the patient temperature was 34.1c.The device was working fine but over the past hours the flow rate was 0.7lpm.The nurse disconnected and reconnected the pads using the proper technique with no flow improvement.They ran diagnostics then the flow rate was 2.4lpm, inlet pressure was -8 psi and the circulation pump command was at 80%.Reconnected pads using proper technique and the issue seemed to be with the trunk pads.Ms&s suggested to try on a second device and if flow still was still low, switch out pads.The nurse called back an hour later and with a second device, the flow was the same so they kept the patient on the first device.Reconnected pads using proper technique, issue seemed to be with the trunk pads.Suggested trying a second device and if still low flow to switch out pads.Called back an hour later and with a second device flow was the same so they kept the patient on first device.The attending did not want to switch out pads since the patient was maintaining target temperature.Ms&s explained to nurse that with flow rate too low the heater will not kick in if the patient dips below the target.In addition, the pads had been in use for 5 days.Ms&s explained that pads are supposed to be switched out every 5 days and would discussed changing the pads again with attending.Additional information was received from mss on 26may2020, that the biomed received the device and stated he attempted to drain the device but no water comes out.The water level showed 3 bars.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿belt temperatures too low after nip roller and heated section.¿ it was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.Corrections: d10, h3 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.

Event Description

It was reported that there was a low flow on the arctic sun device.The device was maintaining patient temperature at 34c.Now the patient temperature was 34.1c.The device was working fine but over the past hours the flow rate was 0.7lpm.The nurse disconnected and reconnected the pads using the proper technique with no flow improvement.They ran diagnostics then the flow rate was 2.4lpm, inlet pressure was -8 psi and the circulation pump command was at 80%.Reconnected pads using proper technique and the issue seems to be with the trunk pads.Ms&s suggested trying on a second device and if flow was still low, switch out pads.The nurse called back an hour later and with a second device, the flow was the same, so they kept the patient on the first device.Reconnected pads using proper technique, issue seems to be with the trunk pads.Suggested trying a second device and if still low flow to switch out the pads.Called back an hour later and with a second device flow was the same, so they kept the patient on first device.The attending did not want to switch out the pads since the patient was maintaining target temperature.Ms&s explained to nurse that with flow rate too low the heater will not kick in if the patient dips below the target.In addition, the pads had been in use for 5 days.Ms&s explained that pads are supposed to be switched out every 5 days and would discuss changing the pads again with attending.Additional information was received from mss on 26may2020, that the biomed received the device and stated they attempted to drain the device but no water came out.The water level showed 3 bars.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10155246
• MDR Text Key: 207895232
• Report Number: 1018233-2020-03844
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• 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: 07/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1