BEUDAMED
    FDA Adverse Event Other Summary report: N

    WOLF-PAK

    MDR report key: 2267911 · Received September 26, 2011

    Report

    Report Number
    3009089744-2011-00005
    Event Type
    Other
    Date Received
    September 26, 2011
    Date of Event
    March 1, 2011
    Report Date
    September 23, 2011
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD. E. SEABOARD INDUS ESTATE
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD RETURNED DEVICE FOR THE MEDPRO ELASTOMERIC INFUSION PUMPS OF 2.0 ML/HOUR SHOWED A HIGHER FLOW RATE WAS RECEIVED IN (B)(4) 2011 AND TESTED. TEST CONFIRMED THE DEVICE HAS A POTENTIAL FOR OVER-INFUSION. NO FIELD FAILURE DEVICE WAS RECEIVED FOR THE OTHER TWO INCIDENTS. MFR DECIDED TO RECALL THE CONCERNED LOTS. INCOMPLETE UV GLUE ADHESION AT THE GLASS TUBE AND PVC TUBE INTERFACES IN A SMALL PORTION OF ASSEMBLY RESULTED IN THE MALFUNCTION. TESTING OF RETENTION SAMPLES FROM THE LOTS AND OTHER LOTS SHOWED NO POTENTIAL FOR OVER-INFUSION - ALL TEST RESULTS SHOWED WITHIN SPECIFICATION PUBLISHED IN ISO 28620: 2010. MFR DECIDED TO TAKE THE CONSERVATIVE STAND AND RECALL NOT ONLY MEDICAL DEVICE WITH ALL LOT NUMBERS WITH CATALOG NUMBER CT-0020-240 MODEL, BUT ALL CATALOG NUMBERS USING THE GLASS CAPILLARY CONFIGURATIONS IN EUROPE, THE UNITED STATES AND ALL COUNTRIES THESE LOT NUMBERS ARE SHIPPED TO. THE PURPOSE OF THE RECALL OF THESE LOT NUMBERS IS TO ELIMINATE THE RISK OF OVER-ADMINISTRATION OF DRUG SOLUTIONS AND TO ELIMINATE ANY RISK AND HARM TO THE PTS.

    Description of Event or Problem · 1

    BELOW ARE THE 3 EVENTS THAT WERE REPORTED BY MEDPRO'S EUROPEAN REP BETWEEN (B)(4) 2011. FIRST EVENT (IN (B)(6)) - THE DEVICE HAS BEEN USED ON (B)(6) FOR POST SURGICAL ANAESTHESIA FOR 24 HOURS ADMINISTRATION (FORESEEN) WITH FENTANIL (FENTANEST 5 FL). THE DEVICE HAS ADMINISTERED THE DRUG IN LESS THAN TWO HOURS. THE PT HAD LOSS OF CONSCIOUSNESS AND RESPIRATORY ARREST. IMMEDIATELY TREATED WITH NALOXONE. MFR INFORMED ON (B)(4) 2011 ((B)(4) LOCAL TIME). REPORTED TO NATIONAL COMPETENT AUTHORITY, (B)(6) 2011 (CASE# (B)(4)). SECOND EVENT (IN (B)(6)) - THE ACCUFLO PUMP WAS FILLED CORRECTLY WITH 5 FU 10,000 MG AND NACL 0.9% ON (B)(6) 2011, BY THE CUSTOMER (B)(6). THE PUMP WAS THEN ATTACHED ON THE SAME DAY AT 10:00 A.M TO THE PT (B)(6). ON (B)(6), THE PT COMPLAINED OF NAUSEA, DIARRHEA AND VOMITING. THE PT WAS TO COME TO THE PHYSICIAN'S SURGERY ((B)(6)) IMMEDIATELY. THERE IT WAS ESTABLISHED AT 12:00 (HR) THAT THE ENTIRE 240 ML HAD ALREADY BEEN ADMINISTERED AFTER APPROX 26 HOURS ALTHOUGH THE ADMINISTRATION WAS TO TAKE 120 HOURS. THE GENERAL CONDITION OF THE PT WAS VERY POOR; HE WAS GIVEN 500ML NACL CELLONDAN 8MG ON THE FIRST DAY TO DILUTE THE 5 FU. ON (B)(6), HE WAS THEN GIVEN DEXAMETHASONE 8MG. ON (B)(6), MET THE PT WHOSE GENERAL CONDITION HAS ALREADY IMPROVED; HOWEVER HE RECEIVED A BLOOD TRANSFUSION THAT DAY NEVERTHELESS. WITH THE RESULT THAT THIS TIME THINGS STILL WENT WELL. NEITHER THE SURGERY NOR THE PT HAS INFORMED ANY MEDIA. PRODUCT USED WAS ACCUFLO ELASTOMERIC INFUSION PUMP SYSTEM, MODEL#: CT-0020-240, LOT#: 90942. INFORMED TO MFR BY EUROPEAN REP ON (B)(4) 2011 (B)(6). EAR REPORTED TO NATIONAL COMPETENT AUTHORITY, (B)(6) ON (B)(6) 2011. (CASE NO. (B)(4)). THIRD EVENT (IN ST (B)(6)) - THE INTENDED DOSE OF 5-FU (5000 MG/ML) EQUIVALENT 10000 MG FU ABSOLUTE, WAS AFTER CORRECT FILLING RELEASED INTO THE PT IN ABOUT 5H INSTEAD OF THE PLANNED 120H. CATALOG NO. CT-0020-240, LOT NO: 90942. THE CASE WAS REPORTED TO THE BFARM BY (B)(6). THE PT WAS ADMITTED TO THE (B)(6) HOSPITAL. MFR INFORMED BY EUROPEAN REP ON (B)(4) 2011 (B)(6). EAR REPORTED TO NATIONAL COMPETENT AUTHORITY ON (B)(6) 2011. (CASE NO. (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOLF-PAK PUMP, ELASTOMERIC INFUSION MEB B. BRAUN MEDICAL PRODUCTION LTD. E. SEABOARD INDUS ESTATE REDI-FLO 90225

    Patients

    Seq Age Sex Outcome Treatment
    1 NA