BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5389491 · Received January 25, 2016

    Report

    Report Number
    9610825-2015-00708
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Report Date
    November 16, 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 · 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 (FULL FILLED) EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS VISUALLY EXAMINED. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED AND THE PATIENT CONNECTOR WAS OPEN. THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED NO SOLUTION (LIQUID) OR CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). FURTHER ON, WE DETECTED NO RESIDUES OF THE SOLUTION (LIQUID) RESPECTIVELY CRYSTALLIZED DRUG RESIDUES AT THE LLA-CONE OF THE PATIENT CONNECTOR. A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE WHITE CLAMP AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). LEAKS WERE NOT DETECTED. THE CONNECTION TUBE / LLA-CONE WAS BLOCKED BY GLUE DURING THE MANUFACTURING PROCESS. THE SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. WE CONSIDER THE COMPLAINT AS JUSTIFIED. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE.

    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: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. IN AS RECEIVED CONDITION, THE CLAMP CLIP IS CLOSED AND THE ORIGINAL WING CAP IS NOT OBSERVED AT THE RECEIVED PUMP. BIG TOP CAP IS OPENED AND DISCOFIX CAP IS REMOVED. NO CRYSTALLIZED RESIDUE IS OBSERVED AT THE FILLING PORT. ADDITIONALLY, DETECTED AIR BUBBLE INSIDE MALE LUER LOCK AND CRYSTALLIZED RESIDUE INSIDE LUMEN OF MICROBORE TUBE. CLAMP CLIP IS RELEASED. NO FLOW IS OBSERVED. COMPLAINT SAMPLE IS LEFT FOR 30 MINUTES. THE PUMP REMAINED NOT FLOWING. THE COMPLAINT SAMPLE IS BLOCKED. NO OTHER DEVIATION IS OBSERVED. ANALYSIS: COMPLAINT SAMPLE IS DISSECTED BY SECTION TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE IS DISSECTED AT POINT A (MICROBORE TUBE; BEFORE MALE LUER LOCK). IMMEDIATELY OBSERVED FLOW. AS THE COMPLAINT SAMPLE IS CONTAMINATED WITH CYTOTOXIC, SECTION A IS BROUGHT BACK TO BMI FOR DECONTAMINATION AND FURTHER INVESTIGATION. THE REST OF THE SAMPLE IS DISPOSED AT THE HOSPITAL. AFTER DECONTAMINATION IS DONE, SECTION A IS TESTED WITH LEAKAGE TEST. NO FLOW IS OBSERVED. SECTION A IS BLOCKED. SECTION A IS FURTHER DISSECTED INTO SECTION A-I (MICROBORE TUBE + STEP DOWN TUBE) AND SECTION A-II (STEP DOWN TUBE + GLASS TUBE). SECTION A-I AND A-II ARE TESTED WITH LEAKAGE TEST. FOUND SECTION A-I IS FLOWING. HOWEVER, SECTION A-II IS BLOCKED. THEREFORE, SECTION A-I IS RULED OUT AS THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. INVESTIGATION IS NARROWED DOWN TO SECTION A-II (STEP DOWN TUBE + GLASS TUBE). SECTION A-II IS VIEWED UNDER SMART SCOPE. OBSERVED GLASS TUBE LUMEN IS BLOCKED BY CRYSTALLIZED RESIDUE. CONCLUSION: COMPLAINT SAMPLE IS BLOCKED DUE TO CRYSTALLIZED RESIDUE TRAPPED INSIDE GLASS TUBE LUMEN. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT "JUDGABLE". JUSTIFICATION: 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 DIFFUSION. DRUG: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48113 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 14L01GE261

    Patients

    Seq Age Sex Outcome Treatment
    1