BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3230360 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18702
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS CONFIRMED. VISUAL INSPECTION REVEALED A STRAND OF A METALLIC-LIKE PARTICLE LOCATED ON THE OUTER SURFACE OF THE BLADDER. THE PARTICLE WAS NOT IN THE FLUID PATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE WAS RECIEVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT YET COMPLETED. VISUAL INSPECTION FOUND NO EVIDENCE OF MARKS OR CRACKS ON THE BLADDER. FUNCTIONAL TESTING WAS PERFORMED WHERE THE BLADDER WAS FILLED TO THE NOMINAL VOLUME AND NO CRACKS WERE OBSERVED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE INITIAL EVALUATION DID NOT CONFIRM THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION INFORMATION: DURING ADDITIONAL EVALUATION THE METALLIC-LIKE PARTICLE WAS EXAMINED. A STEREOMICROSCOPIC EXAMINATION REVEALED THAT THE PARTICLE WAS APPROXIMATELY 8.5MM IN LENGTH. AN ENERGY-DISPERSIVE X-RAY SPECTROSCOPY ANALYSIS OF THE PARTICLE CONCLUDED THAT IT WAS PRIMARILY ALUMINUM BELIEVED TO HAVE BEEN INTRODUCED DURING EQUIPMENT SERVICE AND THEN TRANSFERRED ONTO THE BLADDER DURING MANUFACTURING. THE MANUFACTURING FACILITY WILL CONDUCT AWARENESS TRAINING FOR EMPLOYEES ACROSS ALL SHIFTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOLFUSOR HAD MARKS OR CRACKS DETECTED ON THE RESERVOIR. THE REPORTER STATED THAT MARKS WERE DETECTED ON THE BLADDER AND LOOKED LIKE CRACKS; HOWEVER, NO EXCESS OF SOLUTION WAS VISIBLE. THIS WAS OBSERVED WHILE FILLING THE DEVICE WITH A (B)(4) SALINE SOLUTION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329012 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12N016

    Patients

    Seq Age Sex Outcome Treatment
    1