BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5486582 · Received March 8, 2016

    Report

    Report Number
    9610825-2016-00099
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Report Date
    February 18, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). STATEMENT FROM MANUFACTURER: DEFINE: RECEIVED ONE PIECE OF USED, EMPTY OF EASYPUMP II LT 125-25-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP AND THE ORIGINAL WING CAP WAS MISSING. THE MALE LUER LOCK WAS CLOSED WITH A COMBI STOPPER. BIG TOP CAP WAS OPENED. OBSERVED CRYSTALLIZED RESIDUE AND CRACK AT FILLING PORT. ADDITIONALLY, OBSERVED CRYSTALLIZED RESIDUE AT MALE LUER LOCK. FURTHER ON, COMPLAINT SAMPLE WAS TAKEN FOR FUNCTIONAL TEST, RESPECTIVELY LEAK TEST. COMPLAINT SAMPLE WAS FILLED WITH 30ML NACL 0.9%. IMMEDIATELY DETECTED LEAK AT FILLING PORT. CONCLUSION: SOLUTION WAS UNABLE TO BE INFUSED INTO THE COMPLAINT PUMP AS THE FILLING PORT WAS CRACKED. AS THE RECEIVED SAMPLE WAS DAMAGED, FURTHER INVESTIGATION ON PUMP SEGMENT IS NOT RUNNING WAS UNABLE TO BE PERFORMED. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT "JUDGABLE". HOWEVER, WE ARE ADDRESSING THE BLOCKAGE COMPLAINT IN CAPA001387 AND CAPA001475, AND CRACK AT FILLING PORT IS ADDRESSED IN CAPA001395.

    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 2 USED AND EMPTY EASYPUMP II LT 125-25-S WITHOUT PACKAGING. THE RECEIVED SAMPLES WERE TAKEN TO A VISUAL INSPECTION. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS MISSING ON THE 2 RECEIVED SAMPLES. THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER, THE PATIENT CONNECTOR WAS CLOSED WITH A COMBI STOPPER ON THE 2 RECEIVED SAMPLES. AFTER OPENING THE TOP CAP WE DETECTED CRYSTALLIZED DRUG RESIDUES AND RESIDUES OF SOLUTION (LIQUID) AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR OF THE 2 RECEIVED SAMPLES. AFTERWARDS THE 2 SAMPLES WERE FILLED UP TO THE NOMINAL VOLUME OF 125 ML WITH NACL 0.9 % AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE PATIENT CONNECTOR AND WAITING FOR 60 MINUTES THE 2 PUMPS WORKED (SOLUTION WAS RUNNING). FURTHERMORE WE TESTED THE FLOW RATE OF THE 2 RECEIVED SAMPLES. NOMINAL: 5 ML/H. ACTUAL: SAMPLE 1: 6.7 ML IN 1 H; 12.6 ML IN 2 HRS AND 79.6 ML IN 17 HRS. SAMPLE 2: 6.8 ML IN 1 H; 12.8 ML IN 2 HRS AND 83.2 ML IN 17 HRS. THE INSPECTED SAMPLES ARE WITHIN OUR SPECIFICATIONS. A FAST FLOW (AS DESCRIBED BY THE CUSTOMER) COULD NOT BE DETERMINED. CONSIDERING THESE SAMPLES WE ASSESS THIS COMPLAINT TO BE NOT JUSTIFIED. MOREOVER WE RECEIVED ONE USED AND EMPTY EASYPUMP II LT 125-25-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. IN AS-RECEIVED CONDITION THE WHITE CLAMP AND THE ORIGINAL WING CAP WERE MISSING AND THE PATIENT CONNECTOR WAS CLOSED WITH A COMBI STOPPER. AFTER OPENING THE TOP CAP WE DETECTED CRYSTALLIZED DRUG RESIDUES AND RESIDUES OF SOLUTION (LIQUID) AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR. AFTER OPENING THE TOP CAP WE DETECTED A CRACK AT THE FILLING PORT (LLI-CONE) AT THE SAMPLE. IN ADDITION, THE SAMPLE WAS FILLED WITH 30 ML NACL 0.9% AND TAKEN TO A FUNCTIONAL TEST RESPECTIVELY LEAK TEST. DURING FILLING WE DETECTED IMMEDIATELY LEAKS AT THE FILLING PORT (LLI-CONE) OF THE SAMPLE. THE INSPECTED SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): FLOW RATE BETWEEN 20 AND 21 HOURS OR NO FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144333 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15D27GE211

    Patients

    Seq Age Sex Outcome Treatment
    1