BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V

    MDR report key: 16251469 · Received January 26, 2023

    Report

    Report Number
    1119779-2023-00077
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 24, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LXG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME:EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDICAL USE A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: CENTRIFUGE WAS TAKEN OUT OF SERVICE. INFORMED CUSTOMER THE PRODUCT IS DISCONTINUED, AND NO SPARE PARTS ARE AVAILABLE. ROOT CAUSE IS NOT DETERMINED, AND THIS COMPLAINT IS NOT A CONFIRMED FAILURE OF THE INSTRUMENT AS THE INSTRUMENT WAS NOT RETURNED TO INVESTIGATE. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6), AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR TRENDS ASSOCIATED WITH THE FAILURE OF ¿SAFETY.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V HAD A ROTOR CRACKED IN MID-SPIN, TUBES WITH BLOOD WHERE CRACKED AND SPILLED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEROFUGE 2001 S/N 4230085 HAD A ROTOR CRACKED IN MID-SPIN, TUBES WITH BLOOD WHERE CRACKED AND SPILLED. NO ONE WAS HURT, NO EXPOSURE TO BLOOD OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V HAD A ROTOR CRACKED IN MID-SPIN, TUBES WITH BLOOD WHERE CRACKED AND SPILLED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEROFUGE 2001 S/N 4230085 HAD A ROTOR CRACKED IN MID-SPIN, TUBES WITH BLOOD WHERE CRACKED AND SPILLED. NO ONE WAS HURT, NO EXPOSURE TO BLOOD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431073 BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V SEE H.10 LXG BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown