BEUDAMED
    FDA Adverse Event Other Summary report: N

    SW TX METH SAN ANTONIO TX 1

    MDR report key: 742349 · Received July 19, 2006

    Report

    Report Number
    1718850-2006-00020
    Event Type
    Other
    Date Received
    July 19, 2006
    Date of Event
    June 21, 2006
    Report Date
    June 26, 2006
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFICATION FOR THIS CUSTOM PERFUSION TUBING SET WAS REVIEWED. THE FILTER ORIENTATION WAS CORRECTLY SPECIFIED. THE PLACEMENT OF THE FILTER BACKWARDS IN THE LINE WAS A MANUFACTURING ERROR, MOST LIKELY CAUSED BY THE OPERATOR CONNECTING THE TUBING TO THE INLET AND OUTLET OF THE FILTER AND THEN REVERSING THAT "SUBASSEMBLY" AS IT WAS CONNECTED INTO THE OVERALL LINE. THE PERSONNEL RESPONSIBLE FOR BUILDING THIS PARTICULAR LOT WERE INDENTIFIED AND RETAINED TO EXISTING MANUFACTURING OPERATING PROCEDURES THAT SPECIFY THE CONTROLS DESIGNED INTO THE MANUFACTURING PROCESS TO PREVENT THIS TYPE OF MISASSEMBLY. SINCE THIS PACK WAS MANUFACTURED, THE MANUFACTURING OPERATING PROCEDURES HAVE BEEN UPDATED TO SPECIFY BUILD SEQUENCING FOR ARTERIAL FILTER LOOPS TO PREVENT THIS TYPE OF REVERSAL.

    Description of Event or Problem · 1

    DURING SET-UP, BOTH PACKS OF THIS LOT WERE FOUND TO HAVE BACKWARDS ARTERIAL FILTERS. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SW TX METH SAN ANTONIO TX 1 CUSTOM PERFUSION PACK DTZ COBE CARDIOVASCULAR, INC. NA 0504700095

    Patients

    Seq Age Sex Outcome Treatment
    1 *