BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5427991 · Received February 10, 2016

    Report

    Report Number
    9610825-2016-00033
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    December 9, 2015
    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
    CO
    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). WE RECEIVED ONE USED (FILLED) EASYPUMP II LT 270-54-S IN OPEN PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. WE DETECTED NO DAMAGES OR OTHER DEVIATIONS. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS OPEN AND THE PATIENT END CONNECTOR WAS CLOSED WITH THE ORIGINAL WING CAP. FURTHER ON, WE DETECTED LIQUID AT THE FILLING PORT (LLI-CONE) OF THE SAMPLE. AFTERWARDS THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER STARTING THE PUMP (OPENING THE WHITE CLAMP) AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). LEAKAGES WERE NOT DETECTED AT THE SAMPLE. THE INSPECTED SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. 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). STATEMENT FROM MANUFACTURER: DEFINE: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 270-54-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP WAS CLAMPED AND THE ORIGINAL WING CAP WAS STILL ATTACHED TO THE PUMP. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. OBSERVED SOLUTION RESIDUE AT FILLING PORT. ADDITIONALLY, OBSERVED FILTER PAPER AND MALE LUER LOCK WERE CONTAMINATED WITH UNIDENTIFIED RED STAIN. COMPLAINT SAMPLE WAS THEN TESTED WITH FUNCTIONAL TEST. WING CAP WAS REMOVED AND CLAMP CLIP WAS RELEASED. NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS LEFT FOR 10 MINUTES. HOWEVER, THE PUMP REMAINED NOT WORKING. NO OTHER DEVIATION WAS OBSERVED. NOTE : COMPLAINT SAMPLE WAS DECONTAMINATED BEFORE PROCEEDING WITH FURTHER INVESTIGATION. ANALYSIS: COMPLAINT SAMPLE WAS CHECKED FOR KINKED TUBE. FOUND TRIANGLE TUBE OF COMPLAINT SAMPLE WAS KINKED INSIDE BBC (BIG BOTTOM CAP). HOWEVER, THE PUMP REMAINED NOT WORKING. COMPLAINT SAMPLE WAS THEN DISSECTED BY SECTION TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE WAS DISSECTED AT MICROBORE TUBE, BEFORE MALE LUER LOCK. NO FLOW WAS OBSERVED. THEN, COMPLAINT SAMPLE WAS DISSECTED AT FILTER HUB (MICROBORE TUBE SIDE). NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS FURTHER DISSECTED AT FILTER HUB (TRIANGLE TUBE SIDE). IMMEDIATELY OBSERVED FLOW. THEREFORE, IT CAN BE CONCLUDED THAT THE BLOCKAGE WAS CAUSED BY CONTAMINATED FILTER PAPER. THE DISSECTED SECTIONS WERE THEN TESTED WITH LEAKAGE TEST TO CONFIRM ALL CONNECTIONS WERE NOT BLOCKED. ALL 3 CONNECTIONS (MICROBORE + MLL, MICROBORE + FILTER AND TRIANGLE + FILTER) WERE FLOWING. CONCLUSION: COMPLAINT SAMPLE WAS BLOCKED DUE TO KINKED TRIANGLE TUBE AND CONTAMINATED FILTER PAPER. JUSTIFICATION: JUSTIFIED. 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 (B)(4): PATIENT ARRIVES RETIREMENT INFUSER ON (B)(6) 2015, IS EVIDENCE THAT THE MEDICAL DEVICE CONTAINING THE DRUG AFTER 48 HOURS OF BEING CONNECTED. THIS IS THE TIME PROVIDED FOR THE PASSAGE OF THE CONTENTS OF THE INFUSER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84648 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15D20GE271

    Patients

    Seq Age Sex Outcome Treatment
    1