MAUDE Adverse Event Report: BIOSENSE WEBSTER INC COOL FLOW PUMP,U.S. SHIP KIT; PUMP, CIRCULATING-FLUID, LOCALIZED HEAT

Catalog Number CFP002

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This coolflow® irrigation pump was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow® irrigation pump.It was reported that bubbles were going past the sensor.The pump was not detecting the bubbles.The pump was replaced and the issue resolved.It was confirmed that there were no patient consequences.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The undetected bubbles by the coolflow® irrigation pump was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow® irrigation pump.It was reported that bubbles were going past the sensor.The pump was not detecting the bubbles.The pump was replaced and the issue resolved.It was confirmed that there were no patient consequences.Repair follow-up was performed and po was not provided.No responses from customer.Service was declined.Complaint was unable to be confirmed.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacture's reference number: (b)(4).

• Brand Name: COOL FLOW PUMP,U.S. SHIP KIT
• Type of Device: PUMP, CIRCULATING-FLUID, LOCALIZED HEAT
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7166625
• MDR Text Key: 97500182
• Report Number: 2029046-2017-01322
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071/S5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: CFP002
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 08/24/2018
• Supplement Dates FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1