BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5731911 · Received June 17, 2016

    Report

    Report Number
    9610825-2016-00401
    Event Type
    Malfunction
    Date Received
    June 17, 2016
    Report Date
    May 23, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). CUSTOMER CONFIRMED THAT THE ITEM AND BATCH NUMBER ARE UNKNOWN. IN ADDITIONAL, THE SAMPLE WAS DISCARDED AND NOT SAVED FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN A SAMPLE, ITEM AND LOT NUMBER. NO ADDITIONAL INFORMATION WAS PROVIDED, BECAUSE OF THIS, FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE AND NO CONCLUSION COULD BE DRAWN. HENCE, THE COMPLAINT IS ASSESSED TO BE NOT "JUDGABLE". IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    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 INTERNAL REPORT NUMBER (B)(4). WE RECEIVED ONE USED AND FILLED EASYPUMP II ST 250-1-S-US WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. DAMAGES WERE NOT DETECTED. AS-RECEIVED CONDITION THE WHITE CLAMP IS CLOSED, THE PATIENT CONNECTOR WAS CLOSED WITH THE ORIGINAL WING CAP. FURTHER ON, WE DETECTED LIQUID AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR (LLA-CONE) OF THE SAMPLE. ADDITIONALLY THE PUMP WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER STARTING THE PUMP AND WAITING FOR 60 MINUTES THE PUMP IS WORKING (SOLUTION WAS RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE RECEIVED SAMPLE IS WITHIN OUR SPECIFICATIONS. DEVICE HISTORY RECORDS (DHR):- REVIEWED DEVICE HISTORY RECORDS, THERE IS NO ABNORMALITIES AND NO SUCH DEFECT DETECTED AT FINAL CONTROL INSPECTION. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: UNKNOWN EASY PUMP REF # AND LOT # REPORTS DID NOT INFUSE WHILE CONNECTED TO PATIENT OVER NIGHT. WHEN PUMP REMOVED FROM PATIENT IT STILL DID NOT RUN. PATIENT WAS CONNECTED TO EASYPUMP 250/250 FOR AT LEAST 45 MINUTES AND PUMP DID NOT INFUSE, NURSE VERIFIED CLAMP WAS OPEN AND TUBING WAS NOT KINKED. AFTER PUMP WAS DISCONNECTED FROM PATIENT, PUMP STILL DID NOT INFUSE. MEDICATION IN PUMP WAS VANCOMYCIN 1500MG. "PATIENT" DID NOT EXPERIENCE ANY COMPLICATIONS. NO PATIENT INJURY REPORTED. SAMPLE WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387853 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG 16B21GE711

    Patients

    Seq Age Sex Outcome Treatment
    1