BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING PACK BEQ-TOP 2202

    MDR report key: 7758988 · Received August 7, 2018

    Report

    Report Number
    2248146-2018-00477
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    July 12, 2018
    Report Date
    February 27, 2020
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: IT WAS REQUESTED BY THE EVALUATOR THAT THE DEVICE NOT GET SANITIZED PRIOR TO THE EVALUATION SINCE THE EVENT OCCURRED PRIOR TO CLINICAL USE, DURING PRIMING. THE RETURNED PRE-BYPASS FILTER WAS EXAMINED FOR ANYTHING THAT COULD CAUSE A CLOG. THERE WAS RED LIQUID CONTAMINATION NOTED IN THE FILTER. PRE-BYPASS FILTERS ARE ASSEMBLED DRY AND RED LIQUID WOULD LIKELY HAVE BEEN NOTICED DURING ASSEMBLY; THIS CONTAMINATION WAS MOST LIKELY INTRODUCED DURING PRIMING / USE. THE REPORTED EVENT WAS CONFIRMED. BASED ON THE INVESTIGATION THE MOST LIKELY CAUSE OF THE PRE-BYPASS FILTER CLOG WAS DETERMINED TO BE CONTAMINATION INTRODUCED DURING THE PRIMING / USE BY THE CUSTOMER. THE RETURNED PRE-BYPASS FILTER WAS EXAMINED FOR ANYTHING THAT COULD CAUSE A CLOG. THERE WAS RED LIQUID CONTAMINATION NOTED IN THE FILTER. PRE-BYPASS FILTERS ARE ASSEMBLED DRY AND RED LIQUID WOULD LIKELY HAVE BEEN NOTICED DURING ASSEMBLY; THIS CONTAMINATION WAS MOST LIKELY INTRODUCED DURING PRIMING / USE. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRIMING OF A NEONATAL CIRCUIT IT WAS NOTED THAT A FILTER CONNECTED TO THE PRIMING BAG WAS "CLOGGED". THE CUSTOMER COULDN'T GET FLOW THROUGH IT DURING THE CRYSTALLOID PRIME AND HAD TO USE THE "BRIDGE" PORTION OF THE PRIMING SYSTEM. THIS OCCURRED PRIOR TO USE ON PATIENT AND THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRIMING OF A NEONATAL CIRCUIT IT WAS NOTED THAT A FILTER CONNECTED TO THE PRIMING BAG WAS "CLOGGED". THE CUSTOMER COULDN'T GET FLOW THROUGH IT DURING THE CRYSTALLOID PRIME AND HAD TO USE THE "BRIDGE" PORTION OF THE PRIMING SYSTEM. THIS OCCURRED PRIOR TO USE ON PATIENT AND THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. COMPLAINT # (B)(4), RECORD # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING OF A NEONATAL CIRCUIT IT WAS NOTED THAT A FILTER CONNECTED TO THE PRIMING BAG WAS "CLOGGED". THE CUSTOMER COULDN'T GET FLOW THROUGH IT DURING THE CRYSTALLOID PRIME AND HAD TO USE THE "BRIDGE" PORTION OF THE PRIMING SYSTEM. THIS OCCURRED PRIOR TO USE ON PATIENT AND THERE WAS NO PATIENT INVOLVEMENT. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600939 CUSTOM TUBING PACK BEQ-TOP 2202 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000041407

    Patients

    Seq Age Sex Outcome Treatment
    1