MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS

Device Problems Display or Visual Feedback Problem (1184); Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)

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.The patient was rewarming and the patient temperature was 33.7c.Rewarm read from 33.9c, water temperature was 29.5c, flow rate was 0.4lpm-0.5lpm.The device had been getting alert 113.Ms&s had her disconnect and reconnect pads using proper technique with the flow rate reading stopped.They took off the fluid delivery line and ran diagnostics.Flow rate was went up to 2.1lpm , inlet pressure was -12psi and circulation pump was in 50 range.With the reconnection, the flow rate went up to the 2 range but then dropped to 0.4lpm with second pad connected and did not rebound when disconnected again.Ms&s explained that there is more than one issue going on here: low flow and alert 113.Ms&s stated it was not worth trying to drain fluid off because the flow rate was too low for the heater to work anyway.Ms&s explained that the device will need to go to biomed labeled with alert 113 and low flow.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure could be " inadequate channel design".The lot number is unknown; therefore, a device history record could not be reviewed.Although the product code is unknown, unknown articgels pads product labeling is found to be adequate based on past reviews.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 low flow.The patient was rewarming and the patient temperature was 33.7c.Rewarm read from 33.9c, water temperature was 29.5c, flow rate was 0.4lpm-0.5lpm.The device had been getting alert 113.Ms&s had her disconnect and reconnect pads using proper technique with the flow rate reading stopped.They took off the fluid delivery line and ran diagnostics.Flow rate was went up to 2.1lpm , inlet pressure was -12psi and circulation pump was in 50 range.With the reconnection, the flow rate went up to the 2 range but then dropped to 0.4lpm with second pad connected and did not rebound when disconnected again.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9764501
• MDR Text Key: 184502834
• Report Number: 1018233-2020-01401
• 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
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• 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: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1