BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAPANESE BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT

    MDR report key: 1905293 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05170
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    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). 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 DISTRIBUTED OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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). DEVICE EVALUATION: ONLY THE MALE LUER AND THE BLUE WINGED CAP OF THE INFUSOR WERE RECEIVED BY BAXTER FOR EVALUATION; THE REST OF THE INFUSOR WAS NOT RETURNED FOR EVALUATION. THE REPORTED CONDITION OF "CRACKED LUER ADAPTOR" WAS CONFIRMED; A VISUAL EXAMINATION FOUND THE MALE LUER AND THE BLUE WINGED CAP TO BE DAMAGED. IN ADDITION, THERE WAS ALSO SOME SORT OF TOOL MARK ON THE DAMAGED LUER AND THE BLUE WINGED CAP. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE PATIENT LUER ADAPTER WAS OBSERVED CRACKED AFTER FILLING. THE DEVICE WAS BEING FILLED WITH POPSCAINE FENTANYL CITRATE HYDRATE. 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 JAPANESE BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10G041

    Patients

    Seq Age Sex Outcome Treatment
    1