BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3832098 · Received March 7, 2014

    Report

    Report Number
    1828100-2014-00187
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DWB
    PMA / PMN Number
    K953901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER DISCUSSION WITH THE FIELD SERVICE REP (FSR), THE ROLLER PUMP LID IS VERY LOOSE, NOT VERY SECURE AND COULD FALL OFF THE PUMP IF BUMPED DURING USE. THIS WOULD LEAD TO A PUMP STOP. THE FIELD SERVICE REP (FSR) INSTALL A NEW ROLLER PUMP LID. THE SUSPECT LID WAS RETURNED TO THE MFR FOR EVAL. IF ADD'L INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    A FIELD SERVICE REP (FSR) REPORTED THAT DURING CUSTOMER REQUESTED TIME AND MATERIAL PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE ROLLER PUMP LID HAD A CRACK NEAR HINGE POINT. THE LID DID NOT MOUNT SECURELY TO ROLLER HEAD DUE TO WORN BLACK PLASTIC MOUNTS. THIS UNIT IS BEING USED FOR ANIMAL RESEARCH-"NOT FOR HUMAN USE." SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138521 TERUMO PERFUSION SYSTEM 8000 8K (ROLLER PUMP) DWB TERUMO CARDIOVASCULAR SYSTEMS CORP 16402

    Patients

    Seq Age Sex Outcome Treatment
    1