BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRA , FPA

    MDR report key: 18336581 · Received December 15, 2023

    Report

    Report Number
    2523676-2023-00761
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 2, 2023
    Report Date
    December 15, 2023
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE AND/OR LOT NUMBER WERE PROVIDED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A SAMPLE AND/OR LOT NUMBER. THE ACTUAL DEFECTIVE DEVICE IS VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. 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. THE INITIAL MDR WAS SUBMITTED ON TIME BUT FAILED. FAILURE OCCURRED DUE TO SUBMISSION UPLOADED AS A .PDF INSTEAD OF A .XML FILE. MESSAGEID: (B)(6). COREID: (B)(6). DATETIME RECEIPT GENERATED: 11-21-2023, 15:12:30 "CDRH HAS RECEIVED YOUR SUBMISSION"

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: IV PUMP CONTINUOUSLY ALARMING FOR AIR BUBBLE ON INSULIN GTT. THE PUMP WAS PRIMED TO RELIEVE ANY POSSIBLE AIR BUBBLES AND NONE HAVE COME OUT FROM THE SUGGESTED PRIMING. THE TUBING AND BAG OF INSULIN ITSELF WERE BOTH CHANGED. THE PUMP WAS TURNED OFF THEN BACK ON TO TRY AND TROUBLESHOOT IT. THE PUMP IS STILL ALARMING FOR AIR BUBBLE. THE INSULIN GTT HAS NOW BEEN CHANGED TO A DIFFERENT PUMP. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114304 SET, ADMINISTRATION, INTRA , FPA FPA B. BRAUN MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown