BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5347258 · Received January 6, 2016

    Report

    Report Number
    9610825-2015-00674
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    November 6, 2015
    Report Date
    December 15, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    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 (HALF FILLED) 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. 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). THE SAMPLE WAS FILLED UP 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 · 0

    EXEMPTION NUMBER E2011009 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN A(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 100-50-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION CLAMP CLIP WAS CLAMPED AND THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. DETECTED CRYSTALLIZED RESIDUE AT FILLING PORT. FURTHER ON, DETECTED CRYSTALLIZED RESIDUE AT MICROBORE TUBE AND MALE LUER LOCK. COMPLAINT SAMPLE WAS THEN TESTED WITH FUNCTIONAL TEST. CLAMP CLIP WAS RELEASED. NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS LEFT FOR 10 MINUTES. HOWEVER, THE PUMP REMAINED NOT WORKING. NO OTHER DEVIATION WAS OBSERVED AT THE PUMP. ANALYSIS: COMPLAINT SAMPLES WERE DISSECTED BY SECTIONS TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE WAS DISSECTED AT POINT A (MICROBORE TUBE; BEFORE MALE LUER LOCK). NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS DISSECTED AT POINT B (FILTER HUB; MICROBORE TUBE SIDE). IMMEDIATELY OBSERVED FOW OF SOLUTION. AS THE COMPLAINT SAMPLE WAS CONTAMINATED WITH CYTOTOXIC DRUG, SECTION A AND B WERE BROUGHT BACK TO BMI FOR DECONTAMINATION AND FURTHER INVESTIGATION. AFTER DECONTAMINATION PROCESS WAS DONE, SECTION A AND B WERE TESTED WITH LEAKAGE TEST. SECTION A (MICROBORE TUBE + MLL) AND B (MICROBORE TUBE + FILTER) WERE BLOCKED. SECTION A WAS FURTHER DISSECTED INTO SECTION A(I) (MICROBORE TUBE + STEP DOWN TUBE) AND A(II) (STEP DOWN TUBE + GLASS TUBE). SECTION A(I) AND A(II) WERE TESTED WITH LEAKAGE TEST. SECTION A(I) WAS BLOCKED. SECTION A(II) WAS FLOWING. THEREFORE, SECTION A(II) WAS RULED OUT FROM POSSIBLE CONTRIBUTOR OF BLOCKAGE. SECTION A(I) WAS VISUALLY INSPECTED. FOUND CRYSTALLIZED RESIDUE AT SECTION A(I). THE MOST POSSIBLE ROOT CAUSE FOR BLOCKAGE AT SECTION A(I) IS BY CRYSTALLIZED RESIDUE. INVESTIGATION WAS CONTINUED WITH SECTION B. SECTION B WAS FURTHER DISSECTED INTO SECTION B(I) (MICROBORE TUBE + FILTER) AND SECTION B(II) (MICROBORE TUBE ONLY). SECTION B(I) AND B(II) WERE TESTED WITH LEAKAGE TEST. SECTION B(I) WAS BLOCKED. SECTION B(II) WAS FLOWING. THEREFORE, SECTION B(II) WAS RULED OUT FROM THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. INVESTIGATION WAS NARROWED DOWN TO SECTION B(I). VIEWED SECTION B(I) UNDER SMART SCOPE. NO ABNORMALITY FOUND. NO EXCESS GLUE OBSERVED AT LUMEN OF MICROBORE TUBE. HOWEVER, OBSERVED CRYSTALLIZED RESIDUE AT LUMEN OF MICROBORE TUBE.THE MOST POSSIBLE ROOT CAUSE FOR BLOCKAGE AT SECTION B(I) IS BY CRYSTALLIZED RESIDUE. CONCLUSION: COMPLAINT SAMPLE IS BLOCKED BY CRYSTALLIZED RESIDUE AT MICROBORE TUBE AND MALE LUER LOCK. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT JUDGEABLE. NOTE: CORRECTIVE MEASURES REGARDING BLOCKAGE DUE TO CRYSTALLIZED RESIDUE HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001475. JUSTIFICATION: NOT JUDGEABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY ((B)(4)): AFTER FILLING THE PUMP WITH 5-FLUOROURACIL AND SALINE SOLUTION, IT WAS ATTACHED TO THE PATIENT. AFTER 24H, THE PATIENT CLAIMED THAT THE PUMP DID NOT EMPTY, JUST A LITTLE BIT. WE HAVE OBSERVED THAT THE PUMP DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7020 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15B28GE261

    Patients

    Seq Age Sex Outcome Treatment
    1