BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5428595 · Received February 10, 2016

    Report

    Report Number
    9610825-2016-00029
    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 3 PIECES OF USED, FILLED OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. COMPLAINT SAMPLE 1: AS RECEIVED CONDITION, CLAMP CLIP WAS CLAMPED AND THE ORIGINAL WING CAP WAS STILL ATTACHED TO THE PUMP. BIG TOP CAP (BTC) WAS OPENED AND DISCOFIX CAP WAS REMOVED. OBSERVED SOLUTION RESIDUE AT BTC. ADDITIONALLY, OBSERVED SOLUTION RESIDUE AT TUBING, FILTER AND MALE LUER LOCK. COMPLAINT SAMPLE 1 WAS THEN TESTED WITH FUNCTIONAL TEST. WHEN WING CAP WAS REMOVED AND CLAMP CLIP WAS RELEASED, NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS LEFT FOR 10 MINUTES. THE PUMP REMAINED NOT FLOWING. NO OTHER DEVIATION WAS OBSERVED. COMPLAINT SAMPLE 2: AS RECEIVED CONDITION, CLAMP CLIP WAS CLAMPED AND THE ORIGINAL WING CAP WAS STILL ATTACHED TO THE PUMP. BIG TOP CAP (BTC) WAS OPENED AND DISCOFIX CAP WAS REMOVED. OBSERVED SOLUTION RESIDUE AT FILLING PORT. ADDITIONALLY, OBSERVED SOLUTION RESIDUE AT TUBING, FILTER AND MALE LUER LOCK. COMPLAINT SAMPLE 2 WAS THEN TESTED WITH FUNCTIONAL TEST. WHEN WING CAP WAS REMOVED AND CLAMP CLIP WAS RELEASED, NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS LEFT FOR 10 MINUTES. FLOW WAS OBSERVED. THE PUMP WAS WORKING. NO OTHER DEVIATION WAS OBSERVED. COMPLAINT SAMPLE 3: AS RECEIVED CONDITION, CLAMP CLIP WAS NOT CLAMPED AND THE ORIGINAL WING CAP WAS STILL ATTACHED TO THE PUMP. BIG TOP CAP (BTC) WAS OPENED AND DISCOFIX CAP WAS REMOVED. OBSERVED SOLUTION RESIDUE AT FILLING PORT. ADDITIONALLY, OBSERVED SOLUTION RESIDUE AT TUBING, FILTER AND MALE LUER LOCK. COMPLAINT SAMPLE 3 WAS THEN TESTED WITH FUNCTIONAL TEST. WHEN WING CAP WAS REMOVED AND CLAMP CLIP WAS RELEASED, IMMEDIATELY OBSERVED FLOW OF SOLUTION. THE PUMP WAS WORKING. NO OTHER DEVIATION WAS OBSERVED. ANALYSIS: COMPLAINT SAMPLE 1: COMPLAINT SAMPLE 1 WAS DISSECTED BY SECTION TO INVESTIGATE THE BLOCKAGE POINT. COMPLAINT SAMPLE 1 WAS DISSECTED AT A (MICROBORE TUBE; BEFORE MALE LUER LOCK). NO FLOW WAS OBSERVED. COMPLAINT SAMPLE 1 WAS FURTHER DISSECTED AT B (FILTER HUB; MICROBORE TUBE SIDE). IMMEDIATELY OBSERVED FLOW OF SOLUTION. SECTION A AND B WERE THEN TESTED WITH LEAKAGE TEST. BOTH SECTIONS WERE NOT FLOWING. SECTION A WAS FURTHER DISSECTED INTO SECTION AI (MICROBORE TUBE + STEP DOWN TUBE) AND AII (STEP DOWN TUBE + MALE LUER LOCK). SECTION AI AND AII WERE THEN TESTED WITH LEAKAGE TEST. SECTION AI WAS NOT FLOWING. HOWEVER, SECTION AII WAS FLOWING. THEREFORE, SECTION AII (STEP DOWN + GLASS TUBE) WAS RULED OUT FROM THE POSSIBLE BLOCKAGE CONTRIBUTOR. SECTION AI WAS THEN INSPECTED UNDER SMART SCOPE TO CHECK FOR ANY ABNORMALITY. NO ABNORMALITY WAS OBSERVED AT CONNECTION OF STEP DOWN AND MICROBORE. FOUND LUMEN OF MICROBORE TUBE AND STEP DOWN TUBE WAS BLOCKED BY CRYSTALLIZED RESIDUE. CONCLUSION: SECTION AI (MICROBORE + STEP DOWN) WAS BLOCKED BY CRYSTALLIZED RESIDUE. SECTION B WAS FURTHER DISSECTED INTO BI (MICROBORE + FILTER) AND BII (MICROBORE ONLY) AS WELL. SECTION BI AND BII WERE THEN TESTED WITH LEAKAGE TEST. SECTION BI WAS WORKING. HOWEVER, SECTION BII WAS NOT WORKING. THEREFORE, SECTION BI (MICROBORE + FILTER) WAS RULED OUT FROM THE POSSIBLE BLOCKAGE CONTRIBUTOR. SECTION BII (MICROBORE TUBE ONLY) WAS THEN VISUALLY INSPECTED FOR ABNORMALITY. OBSERVED CRYSTALLIZED RESIDUE INSIDE LUMEN OF MICROBORE TUBE. CONCLUSION: COMPLAINT SAMPLE 1 WAS BLOCKED BY CRYSTALLIZED RESIDUE INSIDE TUBING. CORRECTIVE MEASURES HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001475. COMPLAINT SAMPLE 2 AND 3 WERE FOUND TO BE FLOWING. 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). WE RECEIVED THREE USED, EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED PUMPS WERE TAKEN TO A VISUAL INSPECTION. NO DAMAGES WERE DETECTED. IT WAS INDICATED BY CUSTOMER THAT PUMP WAS INFUSED WITH DRUG - CEFTRIAXONE AND NOT FLOWING (BLOCKAGE). COMPLAINT FORWARDED 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)(4)): NOT FLOWING. DRUG INFUSED: CEFTRIAXONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86292 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15F30GE261

    Patients

    Seq Age Sex Outcome Treatment
    1