BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX INSTRUMENT

    MDR report key: 3777277 · Received January 6, 2014

    Report

    Report Number
    1119779-2014-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    October 31, 2013
    Report Date
    October 31, 2013
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    OOI
    PMA / PMN Number
    K120138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN THE HEALTH OF A PATIENT OR USER; HOWEVER, INFORMATION DOES SUGGEST THAT IF THE DEVICE MALFUNCTION WERE TO RECUR, IT COULD CONTRIBUTE TO AN INJURY. THE BD QUALITY DEPARTMENT INVESTIGATED THE COMPLAINT OF THE BD MAX INSTRUMENT DOOR BEING DIFFICULT TO OPEN AND SLAMMING DOWN. THE COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE ENGINEER ON-SITE. THE INVESTIGATION BY THE FSE FOUND THAT THE "L" SHAPED LEVER WAS DAMAGED, WHICH INDICATES INCORRECT ASSEMBLY/DISASSEMBLY OF THE GAS SPRING OCCURRED AT SOME POINT PREVIOUS TO THIS FAILURE. INVESTIGATION IS UNABLE TO DETERMINE WHEN THIS OCCURRED. THE DOOR HINGE ASSEMBLY WAS REPLACED AND REMOUNTED TO THE GAS SPRING ARM. THE DOOR IS OPERATING AS EXPECTED. THIS IS AN ISOLATED INCIDENT AND THERE ARE NO TRENDS FOR THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THIS BD MAX INSTRUMENT IS HAVING DOOR ISSUES. THE DOOR IS LOOSE AND WHEN OPENED WILL SLIDE CLOSED ON ITS OWN. DOOR HAS COME CLOSE TO DROPPING ON CUSTOMER WHILE THEY ARE PLACING RACKS INSIDE AND CLEANING THE INSTRUMENTS. THE CUSTOMER CONTACTED THE BD TECHNICAL SERVICE AND SUPPORT DEPARTMENT FOR AN ENGINEER TO BE DISPATCHED FOR REPAIR. A FIELD SERVICE ENGINEER FOUND THAT THE "L" SHAPED LEVER BETWEEN THE GAS SHOCK AND THE HINGE WAS WORN OUT AND REQUIRED REPLACEMENT. THE FSE REPAIRED AND TESTED THE DOOR. THE DOOR IS NOW FUNCTIONING AS INTENDED. THE BD MAX SYSTEM IS INTENDED FOR IN VITRO DIAGNOSTIC (IVS) USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. THE BD MAX SYSTEM IS CAPABLE OF AUTOMATED EXTRACTION AND PURIFICATION OF NUCLEIC ACIDS FROM MULTIPLE SPECIMEN TYPES, AS WELL AS THE AUTOMATED AMPLIFICATION AND DETECTION OF TARGET NUCLEIC ACID SEQUENCES BY FLUORESCENCE-BASED PCR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8711 BD MAX INSTRUMENT OOI BD DIAGNOSTIC SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention