BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPE SET, SPECTRA

    MDR report key: 1890527 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00059
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    February 24, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT,
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-POSSIBLE HYPERVOLEMIA. THE CUSTOMER/OPERATOR PRIMED THE SPECTRA WITH NO ALARMS; ADDITIONALLY, THE ALARM CHECKS WERE OK. SHE STARTED THE PROCEDURE AND SPECTRA WAS IN DIVERT PRIME. THE CUSTOMER/OPERATOR WERE CHECKING PLASMA UNITS WITH THE RN AT THE END OF THE DIVERT PRIME (WHICH TOOK ABOUT 9 MINUTES ON THIS PT), WHEN SHE RECEIVED A RETURN PRESSURE HIGH ALARM. WHEN SHE LOOKED AT THE MACHINE, SHE CHECKED THE RETURN LINE CLAMP AND IT WAS OPEN, BUT THE PRIME SALINE BAG WAS BASICALLY EMPTY AND SHE DID NOT KNOW WHERE THE SALINE WENT AND THE PT APPEARED TO HAVE RECEIVED APPROX 600 MLS OF SALINE. SHE CLAMPED OFF THE PT AND BEGAN TROUBLESHOOTING. THEY DID NOT DO RINSEBACK FOR FEAR THE PT HAD RECEIVED ALL THE SALINE. A SECOND PROCEDURE WAS PERFORMED WITH NO ISSUES. THE KIT WAS RETURNED TO CARIDIANBCT FOR INVESTIGATION. IT WAS CONFIRMED THAT THE ROLLER CLAMP WAS INCORRECTLY INSTALLED ON THE RETURN LINE. THE FAILURE RATE FOR THIS TYPE OF MISASSEMBLY IS CURRENTLY (B)(4) AND THEREFORE, TREND ANALYSIS SUGGESTS THAT THE EVENT REPORTED IS RANDOM AND ISOLATED. ROOT CAUSE: THE CAUSE OF THIS DEFECT WAS RELATED TO A MISASSEMBLY, WHERE THE OPERATOR NEGLECTED TO FOLLOW THE APPROPRIATE MFG OPERATING PROCEDURE OF THE DISPOSABLE SET DURING MFG. THE ALARM WAS THE RESULT OF THE ROLLER CLAMP BEING ON THE WRONG LINE. AN INTERNAL HEALTH HAZARD ANALYSIS WAS PERFORMED TO ADDRESS HYPERVOLEMIA IN COBE SPECTRA EXCHANGE PROCEDURES. THE ANALYSIS CONFIRMS THAT THIS FAILURE COULD RESULT IN MODERATE INJURY DUE TO HYPERVOLEMIA IN A TPE PROCEDURE PARTICULARLY IN THE CASE OF PTS WITH ORGAN DYSFUNCTION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. THE FOLLOWING INCIDENT DESCRIPTION WAS PROVIDED TO CARIDIANBCT QA: THE CUSTOMER HAD A "RETURN PRESSURE HIGH" ALARM AND SALINE WAS INFUSING WITH THE ROLLER CLAMP CLOSED. THE PT WAS A (B)(6) PT. THEY RECEIVED APPROX 600 MLS OF EXTRA SALINE AND 1 UNIT OF PRBC POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPE SET, SPECTRA SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT, 950000000 01S15212

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention