BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, FMS2000

    MDR report key: 4143615 · Received August 21, 2014

    Report

    Report Number
    1219702-2014-00005
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    June 3, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLICATED DISPOSABLE SET WAS RETURNED FOR EVAL. UPON RECEIPT, WE WERE UNABLE TO DUPLICATE THE COMPLAINT. THE RETURNED 3-SPIKE SET APPEARED TO BE IN GOOD CONDITION; THE BLOOD WAS WELL CONTAINED INSIDE THE SET. WE CAREFULLY EXAMINED THE ENTIRE 3 SPIKE SET, SPECIFICALLY AROUND THE HEAT EXCHANGER, INCLUDING ALL TUBING AND TUBING CONNECTIONS IN ALL AREAS NEAR THE HEAT EXCHANGER FOR ANY DAMAGES OR DEFECTS WHICH MAY HAVE LED TO LEAKING. NO DAMAGES OR DEFECTS WERE OBSERVED. WE DID NOT OBSERVE ANY BLOOD LEAKING OUT OF THE 3 SPIKE SET. THE BAG WHICH CONTAINED THE RETURNED 3 SPIKE SET WAS ALSO EXAMINED AND THE BAG WAS CLEAN; NO BLOOD CONTAMINATION WAS FOUND. LASTLY, WE APPLIED AIR PRESSURE TO THE HEAT EXCHANGER BY USING A SYRINGE TO MANUALLY INJECT AIR INTO THE LUER CONNECTOR AT THE PT LINE AND NO LEAKS WERE OBSERVED. IN CONCLUSION, WE DID NOT FIND ANY EVIDENCE TO SUGGEST THAT THE PART INCURRED ANY DEFECTS AS A RESULT OF DESIGN, WORKMANSHIP, OR MATERIALS. EACH 3 SPIKE DISPOSABLE SET MANUFACTURED IS AIR PRESSURE TESTED AND UNDERGOES A FINAL VISUAL QUALITY CONTROL INSPECTION PRIOR TO POUCHING AND STERILIZATION. THERE WILL BE NO CORRECTIVE ACTION TAKEN AT THIS TIME DUE TO LOW INCIDENT RATE; HOWEVER, WE WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT CLOSELY.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT, MW 5036906 STATED: ATTEMPTING TO TRANSFUSE BLOOD DURING MASSIVE TRANSFUSION. BELMONT RAPID INFUSER TUBING NOTED TO BE LEAKING DISTAL TO PRESSURE CHAMBER WHERE SMALLER TUBING IS JOINED TO PRESSURE CHAMBER. BLOOD WAS DRIPPING OUT OF HOLE IN TUBING. INFUSION STOPPED - NEW TUBING USED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505798 THE BELMONT RAPID INFUSER, FMS2000 80 LGZ LGZ BELMONT INSTRUMENT CORP. FMS 2000 2013-11 05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK