BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5396915 · Received January 28, 2016

    Report

    Report Number
    9610825-2015-00709
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Report Date
    December 7, 2015
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 MEDICAL INTERNAL REPORT # (B)(4). INVESTIGATION DETAILS. RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 100-50-S-US IN OPEN PACKAGING. IN AS RECEIVED CONDITION, CLAMP CLIP WAS CLOSED AND THE ORIGINAL WING CAP HAD BEEN REPLACED WITH RED CLOSING CONE. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. DETECTED CRYSTALLIZED RESIDUE AT FILLING PORT. ADDITIONALLY, DETECTED CRYSTALLIZED RESIDUE AT FILTER, MICROBORE TUBE AND MALE LUER LOCK. COMPLAINT SAMPLE WAS THEN TESTED WITH FUNCTIONAL TEST. WING CAP WAS REMOVED AND CLAMP CLIP WAS RELEASED. NO FLOW WAS OBSERVED; SAMPLE WAS THEN LEFT FOR 10 MINUTES. THE PUMP REMAINED NOT FLOWING. NO OTHER DEVIATION WAS OBSERVED AT THE PUMP. ANALYSIS: COMPLAINT SAMPLE WAS THEN DISSECTED BY SECTION TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE WAS DISSECTED AT POINT A (MICROBORE TUBE; BEFORE MALE LUER LOCK). NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS DISSECTED AT POINT B (MICROBORE TUBE, AFTER FILTER). . IMMEDIATELY OBSERVED FLOW OF SOLUTION. CONCLUSION: THE ROOT CAUSE OF BLOCKAGE COULD NOT BE COMPREHENDED AS THE COMPLAINT SAMPLE HAS CRYSTALLIZED. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT JUDGEABLE 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 AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). THE SAMPLE AND ALL AVAILABLE INFORMATION WAS FORWARDED TO THE B.BRAUN MELSUNGEN AG FOR FURTHER EVALUATION. THEIR REPORT STATES THE RECEIVED SAMPLE WAS VISUALLY EXAMINED. IN AS-RECEIVED CONDITION THE WHITE CLAMP IS OPENED. 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 AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). CRYSTALLIZED DRUG RESIDUES OR SOLUTION AT THE PATIENT CONNECTOR WERE NOT DETECTED. 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 IN ACCORDANCE WITH OUR REQUIREMENTS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THEIR STATEMENT IS AVAILABLE.

    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). CORRECTION TO FILE ATTACHMENT: CHANGE FROM: INCORRECT MEMO ATTACHED TO INITIAL REPORT BY ERROR. CHANGE TO: CORRECT MEMO TO FILE DATED 01/28/2016.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT EASY PUMP DID NOT INFUSE; MEDICATION USED WAS 5FU, FILLED BY HAND. AND THE PUMP DID NOT INFUSE AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55541 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B.BRAUN MELSUNGEN AG N/A 14K05GE551

    Patients

    Seq Age Sex Outcome Treatment
    1