BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 8651921 · Received May 29, 2019

    Report

    Report Number
    9610825-2019-00189
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Report Date
    May 29, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN MELSUNGEN. DURING THE ANALYSIS OF THE HISTROY LOG FILES IT COULD BE DETECTED TWO PRESSURE AND ONE UPSTREAM ALARM. NO MORE ABNORMAITIES COULD BE DETECTED. AT THE VISUAL INVESTIGATION NO DAMAGES OR OTHER ABNORMAITIES COULD BE DETECTED. DURING THE FUNCTIONAL TEST IT WAS POSSIBLE TO BRING THE PUMP IN OPERATION. THE DOWNSTREAM SENSOR WAS CHECKED. FOR THIS INVESTIGATION THE ELECTRONIC PRESSURE CUT-OFF AND THE MECHANICAL PRESSURE LIMITATION WERE CHECKED. FURTHERMORE THE PRESSURE STABILITY OF THE SAFETY CLAMP CONCERNING THE PERCOLATION (FREE FLOW POSSIBILITY) WAS CHECKED. THE DEVICE FULFILLS THE REQUIRED VALUES ACCORDING TO THE SPECIFICATIONS OF THE TECHNICAL SAFETY CHECK (TSC). DURING AN INSIDE INVESTIGATION IT COULD BE DETECTED THAT THE LOCK BOLT DRIVE WAS SLIGHTLY BENT. THE COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WORKS WITHIN THE SPECIFICATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN UNITED KINGDOM): "FAULTY INFUSION" CUSTOMER INFORMATION: PATIENT WAS RECEIVING A NORALDRENALINE INFUSION WHEN THE PRESSURE SUDDENLY INCREASED, PATIENTS BLOOD STARTED FLOWING BACK INTO GIVING SET. A NEW PUMP AND NEW GIVING SET THEREFORE HAD TO BE USED. THE DATE OF OCCURRENCE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442999 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1