BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK®

    MDR report key: 12300078 · Received August 10, 2021

    Report

    Report Number
    2523676-2021-00238
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 20, 2021
    Report Date
    September 19, 2021
    Product Code
    FPA
    UDI-DI
    04046964182235
    PMA / PMN Number
    K942988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR FURTHER EVALUATION. AS A RESULT OF THIS ISSUE, B. BRAUN HAS INITIATED A VOLUNTARY MEDICAL DEVICE CORRECTION FOR MULTIPLE BATCHES OF THE OUTLOOK® PUMP SETS INCLUDING THE BATCH IDENTIFIED FROM THIS COMPLAINT. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT AFTER 4 HOURS INTO INFUSION LEAKING OCCURRED AT CASSETTE. MEDICATION INFUSING - ARTERIAL LINE FLUIDS (NS + ½ U HEP/ML) DID NOT REQUIRE FURTHER TREATMENT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197158 OUTLOOK® SET, ADMINISTRATION, INTRA FPA 354214 0061777798 04046964182235

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA