BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.5ML PATIENT CONTROL MODULEJAPAN

    MDR report key: 1911114 · Received November 30, 2010

    Report

    Report Number
    6000001-2010-05333
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF LEAKAGE WAS NOT CONFIRMED OR DUPLICATED. VISUAL EXAMINATION SHOWED NO SIGNS OF PHYSICAL DEFECT OR ABNORMALITY. BATCH REVIEW WAS CONDUCTED WITH NO ABNORMALITY OBSERVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) BASAL/BOLUS INFUSOR WITH A PATIENT CONTROL MODULE WAS OBSERVED LEAKING RIGHT AFTER PATIENT USE. THE DEVICE WAS FILLED WITH MORPHINE HYDROCHLORIDE AND NORMAL SALINE. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.5ML PATIENT CONTROL MODULEJAPAN PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10G075

    Patients

    Seq Age Sex Outcome Treatment
    1