BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERO-FUGE 2002 CENTRIFUGE

    MDR report key: 9998719 · Received April 24, 2020

    Report

    Report Number
    1119779-2020-00073
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    April 6, 2020
    Report Date
    June 15, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : CUSTOMER REPORTED THAT THE SEROFUGE INSTRUMENT 4890043 WOULD SPIN WHILE THE LID WAS STILL OPEN. THE CUSTOMER INDICATED THAT IF THE LID WAS OPENED DURING OPERATION, THE INSTRUMENT WOULD NOT STOP SPINNING; HOWEVER, NO ONE WAS HARMED. THE CUSTOMER ORDERED A PCB ASSEMBLY TO REPAIR THE UNIT. THIS IS A CONFIRMED FAILURE OF THE SYSTEM DUE TO A HISTORY OF THIS FAILURE OCCURRING. ASSIGNABLE CAUSES INCLUDE: DEFECTIVE PCB ASSEMBLY THAT CONTROLS LATCH RELEASE, DEFECT LATCH, OR DEFECTIVE BOARD LEVEL COMPONENT. INVESTIGATION OF MATERIAL COULD NOT OCCUR AS MATERIAL WAS NOT RETURNED. THE IMMEDIATE CORRECTION WAS FOR THE CUSTOMER TO ORDER A REPLACEMENT PCB. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR TRENDS ASSOCIATED WITH THE FAILURE OF SAFETY H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD SERO-FUGE¿ 2002 SPEED CENTRIFUGE, SERIAL NUMBER 4890043, WAS SPINNING WITH THE LID OPEN. NO INJURIES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTS THAT, OUT OF WARRANTY SN 4890043, UNIT WILL SPIN WITH LID OPENED AND WITHOUT PRESSING START."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD SERO-FUGE¿ 2002 SPEED CENTRIFUGE, SERIAL NUMBER (B)(4) WAS SPINNING WITH THE LID OPEN. NO INJURIES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTS THAT, OUT OF WARRANTY (B)(4), UNIT WILL SPIN WITH LID OPENED AND WITHOUT PRESSING START."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462352 SERO-FUGE 2002 CENTRIFUGE CENTRIFUGES, EQUIPMENT, AND SUPPLIES LXG BECTON, DICKINSON & CO. 4890043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other