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

Device Problems Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)

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 nurse could not see the water passing through the pads.Per troubleshooting, the pads were disconnected and reconnected , but the issue persisted.The pads had to be switched.

Manufacturer Narrative

The reported event was inconclusive.It was unknown whether the device had met specifications.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section." the lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, labeling review could not be performed.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 the nurse could not see the water passing through the pads.Per troubleshooting, the pads were disconnected and reconnected , but the issue persisted.The pads had to be switched.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10066135
• MDR Text Key: 191531024
• Report Number: 1018233-2020-03237
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1