BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 17162183 · Received June 20, 2023

    Report

    Report Number
    9610825-2023-00283
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 29, 2023
    Report Date
    July 31, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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). HC-PM COMPLAINT PROCESSING RECEIVED NO SAMPLE AND NO PICTURE. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: NO SAMPLE WAS RECEIVED AND THUS A FURTHER EVALUATION AND INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. SUMMARY AND ASSESSMENT: AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED AND THEREFORE THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE COMPLAINT IS ONLY TAKEN TO KNOWLEDGE AND FILED FOR STATISTICAL PURPOSES. HOWEVER, IF THE COMPLAINT SAMPLE WILL BE PROVIDED, THE COMPLAINT WILL BE RE-OPENED ACCORDINGLY. BMI COMPLAINT MANAGEMENT STATEMENT:- BMI RECEIVED NO SAMPLE AND NO PICTURE FOR FURTHER INVESTIGATION. COMPLAINT TO BE FORWARDED TO PRODUCTION. ROOT CAUSE ANALYSIS: MEASURE: REFER TO MANUFACTURING SOP OF ELASTOMERIC INFUSION SYSTEM: 1. HC-MY01-M-5-4-16-002-0. 2. HC-MY01-M-5-4-16-012-0. 3. HC-MY01-M-5-4-16-015-0. 4. HC-MY01-M-5-4-16-044-0. SAMPLE/S EVALUATION: NEITHER SAMPLE NOR PICTURE IS AVAILABLE, HENCE FURTHER INVESTIGATION TO IDENTIFY THE DEFECT AS CUSTOMER DESCRIPTION IS NOT POSSIBLE. ANALYSIS: ACCORDING TO CUSTOMER'S DESCRIPTIONS, LEAKING OCCURRING AT THE BASE OF CAP WHERE DILUENT/DRUG IS ADMIXED. FURTHER INQUIRY WAS POSTED TO UNDERSTAND THE DESCRIPTION "LEAK WAS OCCURRING AT THE BASE OF CAP WHERE DILUENT/DRUG IS ADMIXED.' ADDITION INFORMATION (IT WAS FROM THE TOP. LEAKING WHILE BEING FILLED BEFORE PATIENT USE.') WAS UPDATED IN THE SAP. REVIEWING THE HISTORICAL DATA AND INFORMATION PROVIDED, BELOW ARE THE POTENTIAL ROOT CAUSES OF LEAKAGE AT THE AREA DESCRIBED BY THE CUSTOMER: 1. VALVE LEAKAGE. 2. LEAKAGE DUE TO CRACK AT FILLING PORT. 3. LEAKAGE DUE TO CRACK AT BHT. VALVE LEAKAGE AND CRACK AT FILLING PORT ARE KNOWN ISSUE AND CAPA 172512 AND CAPA 205388 HAVE BEEN INITIATED TO ADDRESS THE ISSUE. AWARENESS TRAINING WAS CONDUCTED (COMPLETION DATE: 2022-12-08 AND 12-30) TO THE MOLDING AND ASSEMBLY OPERATORS ON THE CRACK LINE AT BHT. OPERATORS HAVE TO IMMEDIATELY INFORM SUPERVISOR IF CRACK AT BHT IS OBSERVED FOR IMMEDIATE ACTION. FURTHER INVESTIGATION WILL BE CONDUCTED TO IDENTIFY THE ACTUAL LEAKAGE POINT IF THE SAMPLE RETURNS. SUMMARY OF ROOT CAUSE ANALYSIS: AS NEITHER COMPLAINT SAMPLE NOR PICTURE WAS RECEIVED, FURTHER INVESTIGATION IS NOT POSSIBLE TO IDENTIFY THE COMPLAINED DEFECT. HENCE, THE COMPLAINT IS CLASSIFIED AS NOT CONFIRMED. CAUSE : CAUSE COULD NOT BE DETERMINED NEITHER SAMPLE NOR PICTURE IS AVAILABLE, HENCE FURTHER INVESTIGATION TO IDENTIFY THE DEFECT AS CUSTOMER DESCRIPTION IS NOT POSSIBLE.

    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 REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: PUMP LEAKED AN UNIDENTIFIED AMOUNT OF 5FU INFUSION ON PATIENT DURING 48HR AT-HOME INFUSION. LEAK WAS OCCURRING AT THE BASE OF CAP WHERE DILUENT/DRUG IS ADMIXED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013279 EASYPUMP PUMP, INFUSION, ELASTOMERI MEB B. BRAUN MELSUNGEN AG 4540018-02 22G15GE561 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown