BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3830590 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16832
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM OCTOBER 23, 2013 TO OCTOBER 24, 2013. THE SOLUTION BEING INFUSED WAS 910 MG MORPHINE HYDROCHLORIDE, 8 G DEXAMETHASONE, AND 7 G OF ANOTHER NON-BAXTER SOLUTION. THE PATIENT RECOVERED FROM THE UNCONTROLLABLE PAIN BY AN ADMINISTRATION OF MORPHINE USING A NEW ELASTOMERIC DEVICE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND NO SIGNS OF PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED, AND THE FLOW RATE WAS FOUND TO BE LOWER THAN THE SPECIFICATION RANGE OF THE PRODUCT. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE'S FLOW RESTRICTOR HOUSING WAS DISASSEMBLED, AND THE GLASS CAPILLARY WAS AIR FLOW TESTED; THE AIR FLOW RATE WAS FOUND TO BE LOW. MICROSCOPIC EXAMINATION OF THE GLASS CAPILLARY THEN IDENTIFIED DRUG RESIDUE WITHIN THE COMPONENT. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE THIS DRUG RESIDUE. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INFUSOR UNDERINFUSED. THIS OCCURRED DURING INFUSION OF AN UNKNOWN ANALGESIC DRUG. THE REPORTER STATED THAT THIS LED TO THE PATIENT¿S PAIN NOT BEING CONTROLLED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308197 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13K075

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 910 MG MORPHINE HYDROCHLORIDE| 8 G DESAMETASOME| 7 G ARTROSILENE