BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5511119 · Received March 18, 2016

    Report

    Report Number
    9610825-2016-00133
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    February 21, 2016
    Report Date
    February 25, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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). WE RECEIVED ONE USED AND HALF FILLED EASYPUMP II LT 60-30-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. THE WHITE CLAMP WAS CLOSED AND THE PATIENT CONNECTOR WAS NOT CLOSED, THE ORIGINAL WING CAP WAS NOT HANDED OVER FROM THE CUSTOMER. DAMAGES THAT WOULD LEAD TO A MALFUNCTION WERE NOT DETECTED AT THE SAMPLE. AFTER OPENING THE TOP CAP WE DETECTED SOLUTION AT THE FILLING PORT (LLI-CONE) OF THE SAMPLE. FURTHERMORE WE DETECTED CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE AND AT THE PATIENT CONNECTOR (LLA-CONE). THE SAMPLE WAS FILLED UP TO THE NOMINAL VALUE (60 ML) AND WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY LEAK TEST. AFTER STARTING THE PUMP AND WAITING FOR 60 MINUTES THE PUMP DID WORK (SOLUTION WAS RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE INSPECTED SAMPLE IS WITHIN OUR SPECIFICATIONS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE. REVIEWED THE DHR AND THERE IS NO ABNORMALITY FOUND DURING IN-PROCESS AND AT FINAL CONTROL INSPECTION.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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). STATEMENT FROM MANUFACTURER: DEFINE: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 60-30-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP WAS CLAMPED AND THE ORIGINAL WING CAP WAS NOT OBSERVED AT THE PUMP. BIG TOP CAP WAS OPENED. OBSERVED SOLUTION RESIDUE AT FILLING PORT. ADDITIONALLY, DETECTED CRYSTALLIZED RESIDUE OUTSIDE THE SAMPLE AND AT MALE LUER LOCK. COMPLAINT SAMPLE WAS FILLED UP UNTIL THE NOMINAL VOLUME (60 ML) AND TAKEN FOR FUNCTIONAL TEST, RESPECTIVELY LEAK TEST. AFTER 60 MINUTES, THE PUMP WAS WORKING. NO OTHER DEVIATION WAS OBSERVED. CONCLUSION: BLOCKAGE DEFECT AS MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THEREFORE, THE COMPLAINT IS CLASSIFIED AS NOT "JUDGABLE".

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)):NO INFUSION. DRUG: PRIMPERAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166047 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15C14GE231

    Patients

    Seq Age Sex Outcome Treatment
    1