BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT®

    MDR report key: 18300171 · Received December 11, 2023

    Report

    Report Number
    2523676-2023-00817
    Event Type
    Death
    Date Received
    December 11, 2023
    Report Date
    November 6, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964186127
    PMA / PMN Number
    K142036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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). *CORRECTION: THIS REPORT IS BEING SUBMITTED TO UPDATE SECTIONS: SECTION B1 - MARK ADVERSE EVENT. SECTION B2 - MARK DEATH & LIFE-THREATENING. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NONCONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. A CLOSE VISUAL EVALUATION WAS PERFORMED ON ALL RETAINS AND NO DEFECTS WERE OBSERVED. IN AN ATTEMPT TO REPLICATE THE REPORTED DEFECT OF THE AIR-IN-LINE ALARM ON THE PUMP, ALL RETAINS WERE ATTACHED TO THE PUMP AND DID NOT HAVE TO BE STRETCHED TO FIT THE PUMP. RETAINS WERE THEN TESTED BY RUNNING THERAPY WHILE STAGGERING THE FLOW RATE THROUGHOUT THE THERAPY. NO ALARMS OCCURRED DURING THE TESTING OF THE RETAINS. ALL RETAINS WERE ALSO LEAK TESTED WITH PASSING RESULTS. A MEASUREMENT OF THE OUTER DIAMETER OF THE PUMP SEGMENT TUBING WAS TAKEN AND FOUND TO BE 0.152 INCHES WHICH MEETS THE SPECIFICATION OF 0.150-0.154 INCHES. CORRECTIVE ACTIONS WERE PERFORMED TO REVISE SPECIFICATIONS WHICH LIMIT UNIT-TO-UNIT VARIATION IN TUBING OUTER DIAMETERS AND INCREASED THE LENGTH OF THE TUBING THAT CONTACTS THE AIR SENSOR. THE REDUCED VARIATION IN TUBING OUTER DIAMETER AND LENGTH REVISION IMPROVES THE COUPLING BETWEEN THE ADMINISTRATION SET AND THE AIR-IN-LINE SENSOR REDUCING THE POTENTIAL FOR FALSE AIR-IN-LINE ALARMS. B. BRAUN MEDICAL INC. HAS INITIATED A VOLUNTARY MEDICAL DEVICE CORRECTION 2523676-9/26/23-004-C FOR MULTIPLE BATCHES OF INFUSOMAT® PUMP SETS MANUFACTURED BETWEEN 01.JAN.2022 AND 17.AUG.2023. 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 · 0

    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 · 0

    AS PER MEDWATCH MW5148158: "PATIENT HAD LAPAROSCOPIC SURGERY WITH SMALL INTESTINE RESECTION ON (B)(6) 2023. ON (B)(6) 2023 AT 2355 PATIENT BECAME HYPOTENSIVE (BP 75/50), TACHYCARDIC (HR 20'S), AND TACHYPNEIC (RR HIGH-40'S). RAPID RESPONSE CALLED AND THE PATIENT WAS TRANSFERRED TO THE ICU. UTILIZING THE BBRAUN INFUSOMAT SPACE PUMPS THE PATIENT WAS STARTED ON LEVOPHED, AND THEN VASOPRESSIN AND NEOSYNEPHRINE ARE ADDED. THE BBRAUN ADMINISTRATION SETS UTILIZED (INFUSOMAT SPACE 15 DRIP/ML 120 INCH TUBING) ARE THE SUBJECT OF A BBRAUN URGENT MEDICAL DEVICE CORRECTION NOTICE DATED OCTOBER 23, 2023 AND THIS NOTIFICATION WAS RECEIVED VIA US MAIL AT THE HOSPITAL ON NOVEMBER 6, 2023. THERE ARE NO UNAFFECTED TUBING ADMINISTRATION LOTS IN COMMERCIAL CIRCULATION AT THIS TIME WITH NEW IMPROVED INVENTORY DUE ON NOVEMBER 30, 2023 PER THE BBRAUN DEVICE CORRECTION NOTICE. AS NOTED IN THE CORRECTION NOTICE BBRAUN HAS IDENTIFIED THAT THEIR OUTER DIAMETER TUBING MAY VARY IN SIZE LEADING TO INCREASED AIR ALARMS, INCLUDING FALSE AIR ALARMS AS WELL AS THE CREATION OF MICROBUBBLES IN THE TUBING ADMINISTRATION SETS, FURTHER LEADING TO ADDITIONAL AIR ALARMS. DUE TO MULTIPLE AIR ALARMS GENERATED BY THE BBRAUN INFUSOMAT SPACE PUMPS IN USE (8 MULTIPLE BBRAUN INFUSOMAT SPACE PUMPS RUNNING FOR THIS CRITICALLY ILL PATIENT) AS A RESULT OF THE ADMINISTRATION SET ISSUE THIS PATIENT EXPERIENCED FURTHER INSTABILITY LEADING TO THE INTERRUPTION OF THE INFUSION OF VASOPRESSORS, LEVOPHED AND NEOSYNEPHRINE IN A HEMODYNAMICALLY UNSTABLE PATIENT. THE PATIENT HAS SUBSEQUENTLY PASSED AWAY ON (B)(6) 2023. AS SUCH WE ARE REPORTING THIS EVENT TO THE FDA. REFERENCE REPORTS: MW5148159, MW5148160."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045275 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061894137 04046964186127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L