BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIRST MEDICAL SOURCE

    MDR report key: 2223388 · Received August 8, 2011

    Report

    Report Number
    3004605364-2011-00001
    Event Type
    Other
    Date Received
    August 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MEDPRO INTERNATIONAL (THAILAND) LTD
    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. MANUFACTURER DECIDED TO RECALL THE CONCERNED LOTS. INCOMPLETE UV GLUE ADHESION AT THE GLASS TUBE (OUTER DIAMETER) AND THE PVC TUBE (INNER DIAMETER) 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 (B)(4). MANUFACTURER 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 NUMBER USING THE GLASS CAPILLARY CONFIGURATIONS IN (B)(6), THE UNITED STATES, AND ALL COUNTRIES THESE LOT NUMBER ARE SHIPPED TO. THE PURPOSE OF THE RECALL OF THESE LOT NUMBER IS TO ELIMINATE THE RISK OF OVER-ADMINISTRATION OF DRUG SOLUTIONS AND TO ELIMINATE ANY RISK AND HARM TO THE PATIENTS.

    Description of Event or Problem · 1

    BELOW ARE THE 3 EVENTS THAT WERE REPORTED BY MEDPRO'S (B)(4) REPRESENTATIVE BETWEEN (B)(6) 2011. FIRST EVENT (IN (B)(6)) - THE DEVICE HAS BEEN USED ON (B)(6), FOR POST SURGICAL ANESTHESIA FOR 24 HOURS ADMINISTRATION (FORESEEN) WITH FENTANIL (FENTANEST 5 FL.). THE DEVICE HAS ADMINISTERED THE DRUG IN LESS THAN TWO HOURS. THE PATIENT HAD LOSS OF CONSCIOUSNESS AND RESPIRATORY ARREST. IMMEDIATELY TREATED WITH NALOXONE. MANUFACTURER INFORMED ON (B)(4) 2011 ((B)(4) LOCAL). REPORTED TO (B)(6) ON (B)(6) 2011 (CASE NO. (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 PATIENT (B)(6). ON (B)(6), THE PATIENT COMPLAINED OF NAUSEA, DIARRHEA AND VOMITING. THE PATIENT WAS TO COME TO THE PHYSICIAN'S SURGERY (DR. (B)(6)) IMMEDIATELY. THERE IT WAS ESTABLISHED AT 12:00(HR) THAT THE ENTIRE 240 ML HAD ALREADY BEEN ADMINISTERED AFTER APPROXIMATELY 26 HOURS ALTHOUGH, THE ADMINISTRATION WAS TO TAKE 120 HOURS. THE GENERAL CONDITION OF THE PATIENT WAS VERY POOR: HE WAS GIVEN 500 ML NACL WITH CELLONDAN 8 MG ON THE FIRST DAY TO DILUTE THE 5 FU. ON (B)(6), HE WAS THEN GIVEN DEXAMETHASON 8 MG. ON (B)(6), MR (B)(6) (AREA MANAGER OF (B)(4)), MET THE PATIENT WHOSE GENERAL CONDITION HAS CLEARLY 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 PATIENT HAS INFORMED ANY MEDIA. PRODUCT USED WAS ACCUFLO ELASTOMERIC INFUSION PUMP SYSTEM, MODEL NO: CT-0020-240, LOT NO : 90942. INFORMED TO MFR BY (B)(4) REP ON (B)(4) 2011. (B)(6) REPORTED TO (B)(6) ON (B)(6) 2011. (CASE NO. (B)(4)). THIRD EVENT (IN (B)(6)) - THE INTENDED DOSE OF 5-FU (5000 MG/ML) EQUIVALENT 10000 MG FU ABSOLUTE, WAS AFTER CORRECT FILLING RELEASED INTO THE PATIENT IN ABOUT 5H INSTEAD OF THE PLANNED 120H. CATALOG NO. : CT-0020-240, LOT NO. : 90942. THE CASE WAS REPORTED TO (B)(4) BY (B)(6). THE PATIENT WAS ADMITTED TO (B)(6). MANUFACTURER INFORMED BY (B)(4) REPRESENTATIVE ON (B)(4) 2011. (B)(6) REPORTED TO (B)(6) ON (B)(6) 2011. (CASE NO. (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST MEDICAL SOURCE PUMP, ELASTOMERIC INFUSION MEB MEDPRO INTERNATIONAL (THAILAND) LTD FMS EASY-FUSER 91209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA