BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5050414 · Received September 2, 2015

    Report

    Report Number
    9610825-2015-00373
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 11, 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). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM IN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE INSPECTION RESULTS ARE AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED ONE USED (APPROXIMATELY HALF FILLED) EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. DAMAGES OR MANUFACTURING FAULTS WERE NOT DETECTED. IN AS-RECEIVED CONDITION THE WHITE CLAMP IS CLOSED AT THE SAMPLE. THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AND RESIDUES OF FLUID AT THE FILLING PORT (LLI-CONE) AND AT THE LLA-CONE OF THE PATIENT CONNECTOR. THE PUMP WAS FILLED WITH NACL 0.9 % UP TO THE NOMINAL VOLUME (100 ML) AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER WAITING FOR A WHILE THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). THEN THE PUMP WAS SQUEEZED BY HAND AND THE FUNCTIONAL TEST RESPECTIVELY THE LEAK TEST WAS CARRIED OUT AGAIN. SUBSEQUENTLY THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). LEAKAGES WERE NOT DETECTED AT THE RECEIVED SAMPLE. THE RECEIVED SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. MOREOVER WE RECEIVED ONE FURTHER USED (APPROXIMATELY HALF FILLED) EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. DAMAGES OR MANUFACTURING FAULTS WERE NOT DETECTED. AS-RECEIVED CONDITION THE WHITE CLAMP IS CLOSED AT THE SAMPLE. THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AND RESIDUES OF FLUID AT THE FILLING PORT (LLI-CONE) AND AT THE LLA-CONE OF THE PATIENT CONNECTOR. THE PUMP WAS FILLED WITH NACL 0.9 % UP TO THE NOMINAL VOLUME (100 ML) AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER WAITING FOR A WHILE THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). THEN THE PUMP WAS SQUEEZED BY HAND AND THE FUNCTIONAL TEST RESPECTIVELY THE LEAK TEST WAS CARRIED OUT AGAIN. SUBSEQUENTLY THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). LEAKAGES WERE NOT DETECTED AT THE RECEIVED SAMPLE. THE RECEIVED SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. STATEMENT:: RECEIVED TWO PIECE OF USED, FILLED OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. SAMPLE 1: IN AS RECEIVED CONDITION CLAMP CLIP IS CLOSED AND NO WING CAP OBSERVED. BIG TOP CAP IS OPENED. DISCOFIX CAP IS OBSERVED. NO CRYSTALLIZED RESIDUE AT CAP VALVE. ADDITIONALLY DETECTED CRYSTALLIZED RESIDUE AT MALE LUER LOCK AND GLASS TUBE LUMEN. SAMPLE 2: IN AS RECEIVED CONDITION IN FIGURE 1, CLAMP CLIP IS CLOSED AND NO WING CAP OBSERVED. BIG TOP CAP IS OPENED. DISCOFIX CAP IS OBSERVED. NO CRYSTALLIZED RESIDUE AT CAP VALVE. ADDITIONALLY DETECTED CRYSTALLIZED RESIDUE AT MALE LUER LOCK AND GLASS TUBE LUMEN. ANALYSIS: SAMPLE 1: CLAMP CLIP IS RELEASED. NO FLOW IS OBSERVED. COMPLAINT SAMPLE IS DISSECTED BY SECTION TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE IS DISSECTED AT SECTION A (MICROBORE TUBE, BEFORE MALE LUER LOCK). NO FLOW IS OBSERVED. COMPLAINT SAMPLE IS DISSECTED AT SECTION B (MICROBORE TUBE, FILTER). IMMEDIATELY OBSERVED FLOW OF SOLUTION. THE ROOT CAUSE OF BLOCKAGE COULD NOT BE COMPREHENDED AS THE COMPLAINT SAMPLE HAS CRYSTALLIZED. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT JUDGEABLE. SAMPLE 2: CLAMP CLIP IS RELEASED. NO FLOW IS OBSERVED. COMPLAINT SAMPLE IS DISSECTED BY SECTION TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE IS DISSECTED AT SECTION A (MICROBORE TUBE, BEFORE MALE LUER LOCK). NO FLOW IS OBSERVED. COMPLAINT SAMPLE IS DISSECTED AT SECTION B (MICROBORE TUBE, FILTER). IMMEDIATELY OBSERVED FLOW OF SOLUTION THE ROOT CAUSE OF BLOCKAGE COULD NOT BE COMPREHENDED AS THE COMPLAINT SAMPLE HAS CRYSTALLIZED. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT JUDGEABLE. JUSTIFICATION: NOT JUDGEABLE AS THE COMPLAINT SAMPLES HAVE CRYSTALLIZED. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): NO FLOW. DRUG: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581289 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 14G08GE261

    Patients

    Seq Age Sex Outcome Treatment
    1