MAUDE Adverse Event Report: BIOSENSE WEBSTER INC COOLFLOW® IRRIGATION PUMP; SIMILAR DEVICE CFP002, PMA # P990071/S5

Catalog Number CFP001

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a coolflow® irrigation pump and a fire hazard device malfunction occurred.It was reported that during a ventricular extra systole the fuse on the pump overloaded.It smelt like the fuse got burnt.The pump was used to complete the procedure.There was no delay in the procedure.No patient consequences were reported.Additional information was received on (b)(6) 2019.It was confirmed that there was no active fire in the equipment and no staff was in danger at any point.The procedure was completed without irrigation.The reported fire hazard issue was conservatively assessed as a reportable issue.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a procedure with a coolflow® irrigation pump.It was reported that during a ventricular extra systole the fuse on the pump overloaded.It smelt like the fuse got burnt.The pump was used to complete the procedure.There was no delay in the procedure.No patient consequences were reported.Additional information was received on april 11, 2019.It was confirmed that there was no active fire in the equipment and no staff was in danger at any point.The procedure was completed without irrigation.The device was evaluated and replacement of the fuse resolved the issue.The device was also subjected to a preventative maintenance, safety and functional testing and all tests passed.Certificate of conformance was reviewed.It was verified that the device was manufactured in accordance with documented specification and procedures.Manufacturer's reference number: (b)(4).

• Brand Name: COOLFLOW® IRRIGATION PUMP
• Type of Device: SIMILAR DEVICE CFP002, PMA # P990071/S5
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8585046
• MDR Text Key: 145782677
• Report Number: 2029046-2019-03073
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CFP001
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1