BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5427975 · Received February 10, 2016

    Report

    Report Number
    9610825-2016-00030
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    January 15, 2016
    Report Date
    January 18, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 A(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). DEFINE: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP WAS OPENED AND THE ORIGINAL WING CAP HAS BEEN REPLACED WITH WHITE CLOSING CONE. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. OBSERVED SOLUTION RESIDUE AT FILLING PORT. ADDITIONALLY, OBSERVED SOLUTION RESIDUE ALONG THE TUBING, FILTER AND MALE LUER LOCK. THE COMPLAINT SAMPLE WAS THEN TESTED WITH FUNCTIONAL TEST. WHITE CLOSING CONE WAS REMOVED. NO FLOW WAS OBSERVED. THE COMPLAINT SAMPLE WAS LEFT FOR 10 MINUTES. THE PUMP REMAINED NOT FLOWING. NO OTHER DEVIATION WAS OBSERVED AT THE PUMP. ANALYSIS: COMPLAINT SAMPLE WAS DISSECTED BY SECTION TO INVESTIGATE THE BLOCKAGE POINT. COMPLAINT SAMPLE WAS DISSECTED AT A (MICROBORE TUBE; BEFORE MALE LUER LOCK). IMMEDIATELY OBSERVED FLOW OF SOLUTION. SECTION A WAS THEN TESTED WITH LEAKAGE TEST,. NO FLOW WAS OBSERVED. SECTION A WAS FURTHER DISSECTED INTO SECTION AI (MICROBORE + STEP DOWN) AND AII (STEP DOWN + GLASS TUBE). SECTION AI AND AII WERE TESTED WITH LEAKAGE TEST. SECTION AI WAS WORKING. HOWEVER, SECTION AII WAS BLOCKED. THEREFORE, SECTION AI WAS RULED OUT FROM THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. SECTION AII WAS INSPECTED UNDER SMART SCOPE TO CHECK FOR ANY ABNORMALITY. NO ABNORMALITY OBSERVED AT TUBE SURFACE. FOUND LUMEN OF GLASS TUBE WAS BLOCKED BY CRYSTALLIZED RESIDUE. CONCLUSION: COMPLAINT SAMPLE WAS BLOCKED BY CRYSTALLIZED RESIDUE AT GLASS TUBE. CORRECTIVE MEASURES HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001475. JUSTIFICATION: NOT "JUDGABLE".

    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). RECEIVED ONE USED, EASYPUMP II LT 100-50-S WITHOUT PACKAGING. SAMPLE WAS TAKEN TO A VISUAL INSPECTION. NO DAMAGES DETECTED. IT WAS INDICATED BY CUSTOMER THAT PUMP WAS INFUSED WITH DRUG - CEFTRIAXONE AND NOT FLOWING (BLOCKAGE). COMPLAINT SENT TO PRODUCTION FOR INVESTIGATION. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): NOT FLOWING. DRUG INFUSED: CEFTRIAXONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86853 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15E28GE261

    Patients

    Seq Age Sex Outcome Treatment
    1