BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA AUTOPBSC W/SHARPS SET

    MDR report key: 1890524 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00055
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAD EXPERIENCED THE PROBLEM A DAY OR TWO EARLIER. WE DON'T KNOW IF IT WAS THE SAME MACHINE. THEY HAVE 8 AND THEY MOVE THEM AROUND A LOT. THE CUSTOMER'S OPINION WAS THAT THE PROBLEM WAS THE LOOP WAS TOO LARGE AND THE MACHINE. THE CUSTOMER ALSO STATED THAT ALL THE OTHER MACHINES HAVE BEEN RUNNING SINCE WITHOUT A RECURRENCE OF THIS PROBLEM. PM SCHEDULED FOR (B)(4). NO PREVENTATIVE MAINTENANCE PERFORMED FOLLOWING COMPLAINT AS SITE COULD NOT DETERMINE IF MULTIPLE OCCURRENCES TOOK PLACE ON ONE OR MORE MACHINES. ONE DISPOSABLE WAS RETURNED FOR INVESTIGATION. THE TUBING APPEARS TO BE CORRECT LENGTH. IT DOES NOT HAVE A LEAK, BUT HAS ABRASIONS AROUND THE INSIDE CIRCUMFERENCE OF THE PUMP HEADER TUBE (THIN COLLECT LINE). DURING TESTING, THE CARTRIDGE LOADED/UNLOADED ON SPECTRA PUMP HEADERS SUCCESSFULLY 3 TIMES. THE TUBING AT THE LOWER RIGHT TAB IS NOT COMPLETELY GLUED IN PLACE AT PRESENT, BUT ADEQUATE SOLVENT APPEARS TO BE PRESENT. IT IS NOT CLEAR WHETHER THIS ISSUE COULD BE RELATED TO THE CAUSE. IT IS NOT CLEAR WHETHER THIS ISSUE COULD BE THE RESULT OF THE TUBING BEING SNAGGED. THE TUBING DOES GIVE A LITTLE EXTRA STRETCH/LENGTH.

    Description of Event or Problem · 1

    (B)(4). ONE-X, WHILE IN USE ON A DONOR: SPECTRA LOADED AND HPC, APHERESIS STARTED USING AUTO PBSC PROGRAM. ON EXAMINATION, NOTED THAT THE PORTION OF COLLECT LINE TUBING IN THE COLLECT PUMP WAS TOO LONG. THIS CAUSED THE LINE TO BE SHEARED. PROCEDURE STOPPED AFTER 50 MINUTES -NEW MACHINE AND KIT USED TO COMPLETE HPC, APHERESIS. NO ALARM MESSAGES. APPARENTLY, THE CUSTOMER HAD 4 OCCURRENCES ACCORDING TO TECH SERVICE. THE CUSTOMER SAID THAT WHEN THE MACHINE WAS RUNNING, THE PUMP TUBE LOOP WAS TOO BIG AND THAT IT WAS FOLDING AND OCCLUDING AS THE ROLLER RAN ROUND THE HOUSING. THEY STOPPED THE RUN AND LOADED ANOTHER SET AND THIS WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA AUTOPBSC W/SHARPS SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 05S15296

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK