BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5347253 · Received January 6, 2016

    Report

    Report Number
    9610825-2015-00673
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 15, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    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 100-50-S IN OPEN PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED ON THE SAMPLE AND THE PATIENT CONNECTOR WAS CLOSED WITH THE ORIGINAL WING CAP. FURTHER ON, WE DETECTED LIQUID AT THE FILLING PORT (LLI-CONE) OF THE SAMPLE. A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE WHITE CLAMP AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED (LLI-CONE DOES NOT LEAK). THE INSPECTED SAMPLE IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS. 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.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN A(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 100-50-S IN OPEN PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP WAS CLOSED AND THE ORIGINAL WING CAP WAS STILL ATTACHED TO THE PUMP. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. DETECTED CRYSTALLIZED RESIDUE AT FILLING PORT. ADDITIONALLY, DETECTED CRYSTALLIZED RESIDUE AT MALE LUER LOCK. COMPLAINT SAMPLE WAS THEN TESTED WITH FUNCTIONAL TEST. WING CAP WAS REMOVED AND CLAMP CLIP WAS RELEASED. NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS THEN LEFT FOR 10 MINUTES. NO OTHER DEVIATION WAS OBSERVED AT THE PUMP. ANALYSIS: COMPLAINT SAMPLE WAS INSPECTED FOR KINKED TUBE INSIDE BIG BOTTOM CAP. NO ABNORMALITY FOUND. 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 (FILTER HUB; MICROBORE TUBE SIDE). NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS DISSECTED AT POINT C (TRIANGLE TUBE; BEFORE FILTER). NO FLOW WAS OBSERVED. AS THE COMPLAINT SAMPLE WAS CONTAMINATED WITH CYTOTOXIC DRUG, SECTION A, B AND C WERE BROUGHT BACK TO BMI FOR DECONTAMINATION AND FURTHER INVESTIGATION. THE REST OF THE SAMPLE WERE DISPOSED AT MOUNT MIRIAM HOSPITAL. AFTER DECONTAMINATION PROCESS WAS DONE, SECTION A, B AND C WERE TESTED WITH LEAKAGE TEST. SECTION A (MICROBORE TUBE + MLL) WAS FLOWING. SECTION B (MICROBORE TUBE + FILTER) WAS FLOWING AS WELL. SECTION C (TRIANGLE TUBE + FILTER) WAS BLOCKED. THEREFORE, SECTION A AND B WERE RULED OUT FROM THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. INVESTIGATION WAS NARROWED DOWN TO SECTION C. SECTION C WAS THEN INSPECTED UNDER SMART SCOPE. FOUND LUMEN OF TRIANGLE TUBE WAS BLOCKED BY EXCESS CYCLOHEXANONE. CONCLUSION: COMPLAINT SAMPLE WAS BLOCKED DUE TO EXCESS CYCLOHEXANONE AT TRIANGLE TUBE CONNECTION. CORRECTIVE MEASURES REGARDING BLOCKAGE DUE TO EXCESS CYCLOHEXANONE HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001387. JUSTIFICATION: JUSTIFIED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY ((B)(4)): AFTER FILLING THE PUMP, WHEN IT WAS CONNECTED TO THE PATIENT, THE PUMP DID NOT START AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7244 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15B14GE26R

    Patients

    Seq Age Sex Outcome Treatment
    1