BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5347239 · Received January 6, 2016

    Report

    Report Number
    9610825-2015-00672
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    November 24, 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
    TU
    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, COMPLETELY FILLED EASYPUMP II LT 100-50-S WITHOUT PACKAGING (ACCORDING TO THE CUSTOMER CONTAMINATED WITH A CYTOSTATIC DRUG). THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. IN AS-RECEIVED CONDITION THE WHITE CLAMP IS CLOSED. THE ORIGINAL WING CAP WAS NOT ON THE PATIENT CONNECTOR; THE PATIENT CONNECTOR WAS BLOCKED WITH A RED COMBI STOPPER. AFTER OPENING THE TOP CAP WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST, RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER STARTING THE PUMP (REMOVING THE RED COMBI STOPPER) AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE TESTED SAMPLE IS NOT WITHIN OUR SPECIFICATION. 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 CLOSED AND THE ORIGINAL WING CAP HAS BEEN REPLACED WITH RED CLOSING CONE. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. DETECTED CRYSTALLIZED RESIDUE AT FILLING PORT. ADDITIONALLY, DETECTED AIR BUBBLE AT FILTER AND CRYSTALLIZED RESIDUE AT MALE LUER LOCK. THE COMPLAINT SAMPLE WAS THEN TESTED WITH FUNCTIONAL TEST. RED CLOSING CONE WAS REMOVED AND CLAMP CLIP WAS RELEASED. NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS LEFT FOR 10 MINUTES. THE PUMP REMAINED NOT WORKING. NO OTHER DEVIATION WAS OBSERVED. 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. DISSECTION WAS CONTINUED AT POINT B (FILTER HUB; MICROBORE TUBE SIDE). IMMEDIATELY OBSERVED FLOW. AS THE COMPLAINT SAMPLES WERE CONTAMINATED WITH CYTOTOXIC DRUG, SECTION A AND B WERE BROUGHT BACK TO BMI FOR DECONTAMINATION AND FURTHER INVESTIGATION. THE REST OF THE SAMPLE WAS DISPOSED AT MOUNT MIRIAM HOSPITAL. AFTER DECONTAMINATION PROCESS WAS DONE, SECTION A AND B WERE TESTED WITH LEAKAGE TEST. SECTION A (MICROBORE TUBE + MLL) WAS FLOWING. HOWEVER, SECTION B (MICROBORE TUBE + FILTER) WAS NOT WORKING. THEREFORE, SECTION A IS RULED OUT AS THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. INVESTIGATION WAS NARROWED DOWN TO SECTION B. SECTION B WAS THEN INSPECTED UNDER SMART SCOPE. FOUND LUMEN OF MICROBORE TUBE WAS BLOCKED BY EXCESS CYCLOHEXANONE. CONCLUSION: COMPLAINT SAMPLE WAS BLOCKED DUE TO EXCESS CYCLOHEXANONE AT MICROBORE TUBE CONNECTION. CORRECTIVE MEASURES REGARDING BLOCKAGE DUE TO EXCESS CYCLOHEXANONE HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001387. JUSTIFICATION: JUSTIFIED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY ((B)(4)): THE PUMP WAS ATTACHED TO THE PATIENT ON (B)(6) 2015. ON (B)(6) 2015 IT WAS NOTICED THAT THERE HAD BEEN NO DRUG FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7011 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 14N05GE261

    Patients

    Seq Age Sex Outcome Treatment
    1