BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECC SMALL - RESPIRATORY BEQ-TOP 5210 CARDIOPULMONARY TUBING PACK

    MDR report key: 7174293 · Received January 9, 2018

    Report

    Report Number
    2248146-2018-00013
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 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 · 0

    INITIAL MDR SECTION G.5 PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BETTER BLADDER COMPONENT USED WITH ECC SMALL-RESPIRATORY CARDIOPULMONARY TUBING PACK FAILED. THE BETTER BLADDER (ORIGINAL) WAS PART OF A FIELD ACTION INITIATED BY THE VENDOR, AND WAS PULL TESTED PER INSTRUCTIONS SUPPLIED BY THE VENDOR; THE BETTER BLADDER FAILED TESTING PRIOR TO PATIENT USE AND WAS DISCARDED. THE ORIGINAL BETTER BLADDER WAS REPLACED WITH ANOTHER BETTER BLADDER (FIRST REPLACEMENT) WHICH WAS SUPPLIED BY THE VENDOR AS PART OF THE FIELD ACTION. THE FIRST REPLACEMENT BETTER BLADDER FAILED ON 10 DEC 2017. AFTER PASSING TESTING ON WET CIRCUIT IT FAILED AFTER LESS THAN 24 HOURS ON PATIENT. FIRST REPLACEMENT BETTER BLADDER REPLACED WITH A NEW BETTER BLADDER (SECOND REPLACEMENT) WHICH WAS SUPPLIED BY THE VENDOR PER THE ONGOING FIELD ACTION. THE PATIENT WAS ON BYPASS WITH JUMP BRIDGE; PATIENT DID NOT HAVE TO COME OFF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). SECOND REPLACEMENT BETTER BLADDER FAILED ON 11 DEC 2017. BONE WAX WAS APPLIED AT SITE OF PRESSURE PORT CONNECTION TO HOUSING AND WAS ABLE TO CONTINUE TO BE USED. THE SECOND REPLACEMENT BETTER BLADDER WAS STILL IN USE BUT WAS REPORTED TO BE AVAILABLE FOR RETURN AFTER THE PATIENT CAME OFF OF ECMO. ALL THE INVOLVED DEVICES WERE DISCARDED BY THE FACILITY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS REPORT IS FOR THE ORIGINAL BETTER BLADDER SUPPLIED WITH THE TUBING PACK. ONLY ONE DATASCOPE FAIRFIELD ECC SMALL-RESPIRATORY CARDIOPULMONARY TUBING PACK WAS INVOLVED IN ALL THREE EVENTS; THERE WAS NO ALLEGATION AGAINST THE DATASCOPE FAIRFIELD TUBING PACK. REPORT 1 OF 3.

    Additional Manufacturer Narrative · 1

    PATIENT WAS BON ON THE DAY THE EVENT OCCURRED. THE DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. IT WAS DISCARDED BY THE USER. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BETTER BLADDER COMPONENT USED WITH ECC SMALL-RESPIRATORY CARDIOPULMONARY TUBING PACK FAILED. THE BETTER BLADDER (ORIGINAL) WAS PART OF A FIELD ACTION INITIATED BY THE VENDOR, AND WAS PULL TESTED PER INSTRUCTIONS SUPPLIED BY THE VENDOR; THE BETTER BLADDER FAILED TESTING PRIOR TO PATIENT USE AND WAS DISCARDED. THE ORIGINAL BETTER BLADDER WAS REPLACED WITH ANOTHER BETTER BLADDER (FIRST REPLACEMENT) WHICH WAS SUPPLIED BY THE VENDOR AS PART OF THE FIELD ACTION. THE FIRST REPLACEMENT BETTER BLADDER FAILED ON (B)(6) 2017. AFTER PASSING TESTING ON WET CIRCUIT IT FAILED AFTER LESS THAN 24 HOURS ON PATIENT. FIRST REPLACEMENT BETTER BLADDER REPLACED WITH A NEW BETTER BLADDER (SECOND REPLACEMENT) WHICH WAS SUPPLIED BY THE VENDOR PER THE ONGOING FIELD ACTION. THE PATIENT WAS ON BYPASS WITH JUMP BRIDGE; PATIENT DID NOT HAVE TO COME OFF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). SECOND REPLACEMENT BETTER BLADDER FAILED ON (B)(6) 2017. BONE WAX WAS APPLIED AT SITE OF PRESSURE PORT CONNECTION TO HOUSING AND WAS ABLE TO CONTINUE TO BE USED. THE SECOND REPLACEMENT BETTER BLADDER WAS STILL IN USE BUT WAS REPORTED TO BE AVAILABLE FOR RETURN AFTER THE PATIENT CAME OFF OF ECMO. ALL THE INVOLVED DEVICES WERE DISCARDED BY THE FACILITY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS REPORT IS FOR THE ORIGINAL BETTER BLADDER SUPPLIED WITH THE TUBING PACK. ONLY ONE DATASCOPE FAIRFIELD ECC SMALL-RESPIRATORY CARDIOPULMONARY TUBING PACK WAS INVOLVED IN ALL THREE EVENTS; THERE WAS NO ALLEGATION AGAINST THE DATASCOPE FAIRFIELD TUBING PACK. REPORT 1 OF 3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20777 ECC SMALL - RESPIRATORY BEQ-TOP 5210 CARDIOPULMONARY TUBING PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000056130

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA