BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASAL/BOLUS INFUSOR, 12 PACK0.5ML/H X 15 MIN

    MDR report key: 1982836 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00783
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE REPORTED COMPLAINT INCIDENT FOR OVERINFUSION WAS NOT CONFIRMED. THE SAMPLE EVALUATION DID NOT CONFIRM THE REPORTED CONDITION. THE DEVICE PERFORMED AS EXPECTED. THE FLOW RATES WERE WITHIN SPECIFICATION RANGE. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE (1) BASAL/BOLUS INFUSOR OVER-INFUSED DURING PATIENT USE AT THE HOSPITAL. ACCORDING TO THE REPORT, THE DEVICE ACTUALLY INFUSED IN 10 HOURS; HOWEVER, IT IS UNKNOWN WHAT THE EXPECTED INFUSION DURATION WAS. THE DEVICE WAS CONNECTED VIA AN IMPLANTABLE PORT (ACCESS SITE UNKNOWN). THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASAL/BOLUS INFUSOR, 12 PACK0.5ML/H X 15 MIN PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J073

    Patients

    Seq Age Sex Outcome Treatment
    1