BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUNCTIONALLY CLOSED WBC SET

    MDR report key: 1984058 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00118
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    May 5, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN THEY CONNECTED THE SPECTRA RETURN LINE TO THE BLOOD WARMER TUBING, THE BLUE CAP ON THE RETURN LUER WAS VERY TIGHT AND DIFFICULT TO REMOVE. AFTER THE LINES WERE CONNECTED, THEY ELEVATED THE RETURN LUER BY LOOPING THE TUBING OVER THE IV POLE. THE BLOOD WARMER WAS CONNECTED TO THE IV POLE JUST ABOVE THE SPECTRA MACHINE. THE RETURN LUER WAS LOCATED AT SAME HEIGHT ABOVE THE END OF THE BLOOD WARMER TUBING (PT ACCESS). THE CLINICIAN OBSERVED AIR BEING DRAWN IN AT THE RETURN LUER DURING THE PRIMING PROCEDURE WHEN THE SPECTRA SCREEN SHOWED THE MESSAGE, "PRIME ACCESS, RETURN CONNECTIONS (AND SPECTRATHERM LINE)." THIS SCREEN APPEARS DURING SALINE PRIME, BEFORE A PT IS CONNECTED. THE OBSERVATION IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE SOLVENT DURING MFG. AFTER THE RETURN LUER IS BONDED TO THE RETURN TUBING, EXCESSIVE SOLVENT MAY LEAK DOWN INTO THE BLUE CAP AND WICK UP INTO THE LUER. THE SOLVENT THEN EATS AWAY AT THE RETURN LUER FORMING A ROUGH AREA THAT CORRESPONDS TO THE INTERIOR OF THE BLUE CAP. SUCH A DEFECTIVE MALE LUER IS STILL ABLE TO CONNECT TO THE FEMALE LUER ON BLOOD WARMER TUBING, BUT THE POINT EXPOSED TO EXCESS SOLVENT FORMS A LEAK PATHWAY. EXCESS SOLVENT WAS NOTED AT THE RETURN LUER. A LEAK WAS OBSERVED WHEN THE RETURN LUER AND BLOOD WARMER CONNECTION WAS TESTED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS. THE INFUSION OF AIR BUBBLES TO THE RETURN LINE WAS READILY VISIBLE TO THE CLINICIANS SO THEY STOPPED THE PROCEDURES BEFORE CONNECTING PATIENTS. CONCLUSION: A DEVICE FAILURE CONTRIBUTED TO THIS EVENT. A CAPA HAS BEEN OPENED FOR THIS FAILURE MODE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. THE FOLLOWING INCIDENT DESCRIPTIONS WERE PROVIDED TO CARIDIANBCT QUALITY ASSURANCE BY THE CUSTOMER. DURING SALINE PRIME, AIR WAS PULLED INTO THE TUBING AT THE CONNECTION BETWEEN THE SPECTRA RETURN LINE TUBING AND THE BLOOD WARMER TUBING. THE PT WAS NOT CONNECTED TO THE DISPOSABLE TUBING DURING THE INCIDENT AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY DUE TO AIR TO DONOR. NO PT WAS INVOLVED, SO NO PT IDENTIFIED WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUNCTIONALLY CLOSED WBC SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT NA 01S15239

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention