BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5311265 · Received December 18, 2015

    Report

    Report Number
    9610825-2015-00641
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Report Date
    November 27, 2015
    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 · 1

    (B)(4). WE RECEIVED ONE USED, NEARLY EMPTY EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS OPEN AND IS BEND. THE ORIGINAL WING CAP WAS NOT ON THE PATIENT CONNECTOR; THE WING CAP WAS NOT HANDED OVER BY THE CUSTOMER. AFTER OPENING THE TOP CAP WE DETECTED RESIDUES OF SOLUTION (LIQUID) AND CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). IN ADDITION, WE DETECTED A CRACK AT THE FILLING PORT (LLI-CONE). THE SAMPLE WAS FILLED TO THE NOMINAL VOLUME OF 100 ML WITH NACL 0.9 % AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER STARTING THE PUMP (CLIP IS STILL BENT) AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED (LLI-CONE DOES NOT LEAK). THE INSPECTED SAMPLE IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN-PROCESS AND FINAL CONTROL INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). STATEMENT FROM OUR MANUFACTURER: DEFINE: RECEIVED ONE PIECE OF USED NEARLY EMPTY OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. THE RETURNED SAMPLE WAS CONTAMINATED WITH CYTOTOXIC DRUG. ANALYSIS: ACCORDING TO BBM INVESTIGATION, THE RETURNED SAMPLE HAS BECAME BLOCKED. ADDITIONALLY, CRYSTALLIZATION RESIDUE WAS OBSERVED AT FILLING PORT. COMPLAINT SAMPLE WAS MOST POTENTIALLY BLOCKED BY CRYSTALLIZATION RESIDUE AT THE PUMP. CONCLUSION: DEVIATION OF FAST FLOW RATE COULD NO LONGER BE OBSERVED AT THE COMPLAINT SAMPLE. THEREFORE, THE COMPLAINT IS CLASSIFIED AS NOT JUDGEABLE. REMARKS: CORRECTIVE MEASURES HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): FAST FLOW (16 HOURS INSTEAD 48 HOURS). DRUG: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836927 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15A13GE261

    Patients

    Seq Age Sex Outcome Treatment
    1