BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAPANESE BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT

    MDR report key: 2070983 · Received April 27, 2011

    Report

    Report Number
    6000001-2011-03230
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FLOW CONDITION NOT CONFIRMED. VISUAL EXAMINATION OF THE UNIT FOUND NO SIGNS OF ABNORMALITY ON THE BLADDER OR ON OTHER PARTS. A FUNCTIONAL TEST WAS SUBSEQUENTLY PERFORMED BY MANUALLY FILLING THE BLADDER WITH DEXTROSE SOLUTION. NO SIGNS OF EXCESSIVE AIR WERE NOTED IN THE BLADDER DURING AND AFTER FILL. FLOW WAS READILY OBSERVED AT THE LUER AFTER FILL. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: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. 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) (B)(4) BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT DEVICE WAS OBSERVED WITH EXCESS AIR IN THE BLADDER DURING FILLING. THE DEVICE WAS BEING FILLED WITH 300ML OF ROPIVACAINE HYDROCHLORIDE HYDRATE AND 6ML OF FENTANYL CITRATE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAPANESE BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J067

    Patients

    Seq Age Sex Outcome Treatment
    1 FENTANYL CITRATE| ROPIVACAINE HYDROCHLORIDE HYDRATE