BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 10195418 · Received June 25, 2020

    Report

    Report Number
    9610825-2020-00119
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    May 19, 2020
    Report Date
    May 16, 2021
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 20D05G8934 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. RECEIVED 1 PICTURE OF USED CAPILLARY HUB OF INTROCAN SAFETY 3 PUR 20G 1.1X32MM-EU. FROM THE OBSERVATION ON THE RECEIVED PICTURE AND BASED ON CUSTOMER DESCRIPTION THE USED CAPILLARY HUB HAVE SHORTER LENGTH OF THE CAPILLARY. THE TEAR OFF PART OF CAPILLARY CANNOT BE SEEN IN THE PICTURES AND THE SURFACE OF THE TORN OFF AREAS WAS NOT VISIBLE. SINCE NO SAMPLE WAS RETURNED, INVESTIGATION WILL BE CONDUCTED BASED ON PHOTO RECEIVED. THE IN-LINE TEST EQUIPMENT IS SUBJECT OF A FREQUENT CALIBRATION AND A REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HEREWITH POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IN-TIME AND WOULD BE MITIGATED. BESIDE THE AUTOMATED 100% IN-LINE TEST EQUIPMENT, INDEPENDENT IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS ON A RANDOM SAMPLE BASIS WILL BE CONDUCTED BY DIFFERENT TEAMS ON A REGULAR BASIS WITHIN THE PRODUCTION PROCESS. HEREWITH A SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. TEAR OFF CAPILLARY MOST LIKELY NOT APPEAR TO BE ATTRIBUTED BY MANUFACTURING PROCESS AS THE DEFECT IS ABLE TO BE DETECTED AND REJECTED BY THE IN-LINE VISION SYSTEM. DAMAGES INDUCED AFTER ASSEMBLY PROCESS IS NOT POSSIBLE SINCE THE CATHETER HAD BEEN PROTECTED WITH PROTECTIVE CAP. BASED ON THE INVESTIGATION ABOVE AND FROM THE CUSTOMER DESCRIPTION, THIS DEFECT IS BELIEVED TO BE CAUSED POSSIBLY BY REINSERTING THE CANNULA INTO CAPILLARY WHICH LEAD TO THE CAPILLARY BEING PIERCED AND LATER GOT TEAR OFF DURING WITHDRAWAL. AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. THE COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORD PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY THROUGH MW5094648: PATIENT WAS STARTED ON A FLOUROURACIL INFUSION WITH BRAUN ELASTOMERIC 2 DAY PUMP (LOT # 19E12GE561) ON MONDAY (B)(6) 2020. SHE CAME TO HAVE THE PUMP DISCONNECTED ON (B)(6) AND REPORTED THAT THE PUMP WAS EMPTY YESTERDAY AND SHE FELT MORE NAUSEOUS THAN LAST TIME SHE RECEIVED THE INFUSION. FDA SAFETY REPORT # (B)(4). NO REPORTER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659907 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 4540018-02 19E12GE561 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1