BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEQ-TOP 5210 ECC PACK

    MDR report key: 7015863 · Received November 9, 2017

    Report

    Report Number
    2248146-2017-00629
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Report Date
    February 27, 2020
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RETURNED PRODUCT BY MANUFACTURING CONFIRMS THAT THE PRESSURE PORT DETACHED FROM THE DEVICE AND INDICATES THAT THIS BETTER BLADDER IS PART OF THE KNOWN EXPANDED RECALL BY THE MANUFACTURER CIRCULAR TECHNOLOGIES, INC (CT). RETURNED TO CT AND CT CONFIRMED IT WAS THEIR BETTER-BLADDER, BB14. CORRECTIVE ACTION IMPLEMENTED BY CT INCLUDES THEIR FIELD ACTION AS WELL AS A PULL TEST DURING MANUFACTURING TO CHECK FOR THE ISSUE. GETINGE RECEIVED A REVISED/AMENDED EXPANDED RECALL LETTER DATED 10/13/2017 FROM CT THAT HAS BEEN CONFIRMED BY FDA ON 10/16/2017. GETINGE HAS ISSUED LETTERS TO CUSTOMERS OF AFFECTED TUBING PACKS CONTAINING THE AFFECTED BETTER BLADDERS TO REVIEW THEIR INVENTORY, ISOLATE ANY RELATED PRODUCTS, CONDUCT A PULL TEST ON THEM, AND RETURN ANY AFFECTED PRODUCT TO CT. (B)(4).

    Additional Manufacturer Narrative · 1

    PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT A PRESSURE PORT CAME OFF THE BETTER BLADDER IN THE BEQ-TOP 5210 ECC PACK. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT. THE DATE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT A PRESSURE PORT CAME OFF THE BETTER BLADDER IN THE BEQ-TOP 5210 ECC PACK. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795445 BEQ-TOP 5210 ECC PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000056130

    Patients

    Seq Age Sex Outcome Treatment
    1