BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5183467 · Received October 28, 2015

    Report

    Report Number
    9610825-2015-00496
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    September 30, 2015
    Report Date
    October 5, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). WE RECEIVED 3 USED (APPROXIMATELY HALF FILLED) EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED SAMPLES WERE TAKEN TO A VISUALLY EXAMINATION. ON THE USED SAMPLES WE DETECTED SEVERAL KNOTS IN THE TUBE, THEREFORE IT WAS NOT POSSIBLE TO CARRY OUT A FUNCTIONAL TEST RESPECTIVELY TO MEASURE THE FLOW RATE OF THIS COMPLAINT SAMPLES. AN EVALUATION OF THE USED SAMPLES WITH REGARD TO THE REASON OF COMPLAINT IS NOT POSSIBLE. THE COMPLAINT IS ONLY TAKEN FOR THE KNOWLEDGE AND FILED FOR STATISTICAL PURPOSE. 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 MANUFACTURER: RECEIVED THREE PIECES OF USED, FILLED OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. SAMPLE (B)(4): IN AS RECEIVED CONDITION, NO CLAMP CLIP AND MALE LUER LOCK IS OBSERVED AT THE PUMP. ADDITIONALLY, OBSERVED THE END OF MICROBORE TUBE IS TIED INTO A KNOT. BIG TOP CAP IS OPENED AND DISCOFIX CAP IS REMOVED. NO SOLUTION/CRYSTALLIZED RESIDUE IS OBSERVED AT FILLING PORT. NO OTHER DEVIATION IS OBSERVED. SAMPLE (B)(4): IN AS RECEIVED CONDITION, NO CLAMP CLIP IS OBSERVED AT THE PUMP. BIG TOP CAP IS OPENED AND DISCOFIX CAP IS REMOVED. DETECTED CRYSTALLIZED RESIDUE AT FILLING PORT. ADDITIONALLY, OBSERVED A KNOT AT MICROBORE TUBE, BEFORE MALE LUER LOCK. FURTHERMORE, DETECTED CRYSTALLIZED RESIDUE AT MICROBORE TUBE AND MALE LUER LOCK. NO OTHER DEVIATION IS OBSERVED. SAMPLE (B)(4): IN AS RECEIVED CONDITION, NO CLAMP CLIP AND WING CAP IS OBSERVED AT THE PUMP. ADDITIONALLY, OBSERVED 3 KNOTS (2 AT MICROBORE TUBE, ONE AT TRIANGLE TUBE) AT THE PUMP. BIG TOP CAP IS OPENED AND DISCOFIX CAP IS REMOVED. DETECTED CRYSTALLIZED RESIDUE AT FILLING PORT. FURTHERMORE, DETECTED CRYSTALLIZED RESIDUE AT TRIANGLE TUBE, MICROBORE TUBE AND MALE LUER LOCK. NO OTHER DEVIATION IS OBSERVED. ANALYSIS: SAMPLE (B)(4): THE KNOT ON MICROBORE TUBE IS MANUALLY UNTIED. IMMEDIATELY DETECTED FLOW . COMPLAINT SAMPLE (B)(4) IS WORKING. SAMPLE (B)(4): THE KNOT COMPLAINT SAMPLE (B)(4) IS MANUALLY UNTIED. NO FLOW IS OBSERVED. COMPLAINT SAMPLE (B)(4) IS NOT WORKING. COMPLAINT SAMPLE IS THEN DISSECTED BY SECTION TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE (B)(4) IS DISSECTED AT POINT A (TRIANGLE TUBE, BEFORE FILTER). IMMEDIATELY OBSERVED FLOW. THEREFORE, SECTION A (PUMP, 'PUMP + STEP DOWN TUBE' AND 'STEP DOWN TUBE + TRIANGLE TUBE') IS RULED OUT FROM POSSIBLE CONTRIBUTOR OF BLOCKAGE. REMARKS: AS THE COMPLAINT SAMPLE IS CONTAMINATED WITH CYTOTOXIC, SECTION A IS DISPOSED AT THE HOSPITAL. SECTION B IS BROUGHT BACK TO BMI FOR DECONTAMINATION AND FURTHER INVESTIGATION. AFTER REMOVING CRYSTALLIZED RESIDUE INSIDE MALE LUER LOCK OF SECTION B, THE SECTION IS TESTED WITH LEAKAGE TEST. OBSERVED AIR BUBBLE COMING OUT FROM THE TUBING. SECTION B IS NOW WORKING. SAMPLE (B)(4): THE TWO KNOTS AT MICROBORE TUBE ARE UNTIED. HOWEVER, ANOTHER KNOT ON TRIANGLE TUBE IS UNABLE TO BE UNTIED. COMPLAINT SAMPLE IS THEN DISSECTED BY SECTION TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE IS DISSECTED AT POINT A (TRIANGLE TUBE, BEFORE KNOT). IMMEDIATELY OBSERVED FLOW. THEREFORE, SECTION A (PUMP, 'PUMP + STEP DOWN TUBE', 'STEP DOWN TUBE + TRIANGLE TUBE') IS RULED OUT FROM THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. REMARKS: AS THE COMPLAINT SAMPLE IS CONTAMINATED WITH CYTOTOXIC, SECTION A IS DISPOSED AT THE HOSPITAL. SECTION B IS BROUGHT BACK TO BMI FOR DECONTAMINATION AND FURTHER INVESTIGATION. SECTION B IS TESTED WITH LEAK TEST BY PURGING AIR INTO THE TUBE. NO AIR BUBBLE/SOLUTION DETECTED. SECTION B IS THEN DISSECTED AT POINT C AND TESTED WITH LEAK TEST. NO AIR BUBBLE/SOLUTION DETECTED. PROCEED DISSECTION AT POINT C AND TESTED WITH LEAK TEST. OBSERVED AIR BUBBLE AND SOLUTION COMING OUT FROM MICROBORE TUBE. CONCLUSION: COMPLAINT SAMPLES (B)(4) ARE BLOCKED DUE TO CRYSTALLIZED RESIDUE TRAPPED INSIDE MALE LUER LOCK. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT JUDGEABLE. JUSTIFICATION: ALL SAMPLES WERE NOT JUDGEABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): THE INFUSERS DID NOT PERFUSE THE DRUG DURING THE 48 HOURS OF ADMINISTRATION (TOTAL OR PARTIALLY). REGARDING THE DATE OF OCCURENCE, THE CUSTOMER MENTIONS (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716418 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15A13GE261

    Patients

    Seq Age Sex Outcome Treatment
    1