BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2922438 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01381
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER ANALYSIS, THE ROOT CAUSE FOR THE INTERNAL BLADDER DAMAGE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A RUPTURED RESERVOIR WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE BLADDER RUPTURED IN A NON-FOOTED POSITION. MICROSCOPIC EVALUATION REVEALED MARKINGS ON THE INTERIOR SURFACE OF THE BLADDER NEAR THE RUPTURE LINE, WHICH INDICATES INTERNAL DAMAGE, AND THIS INTERNAL DAMAGE CONTRIBUTED TO THE BLADDER RUPTURE. THE EXACT ROOT CAUSE WAS NOT DETERMINED; HOWEVER, THIS TYPE OF DEFECT IS INHERED ON THE MANUFACTURING PROCESS. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE ONE (1) CE INTERMATE SV 200 IN WHICH THE RESERVOIR RUPTURED TOWARD THE END OF FILLING WITH ROOM TEMPERATURE SALINE IN THE PHARMACY. THE DEVICE CONTAINED APPROXIMATELY 90CC'S OF SALINE WHEN THE RUPTURE OCCURRED. THE SALINE REMAINED IN THE DEVICE HOUSING. THE CUSTOMER OBSERVED THAT THE RUPTURE RESULTED IN A TEAR ALONG THE UPPER-MIDDLE LENGTH OF THE RESERVOIR. THE CUSTOMER RELAYED THAT THE UNIT WAS THE 4TH OF 7 BEING FILLED IN SUCCESSION ON A BAXA REPEATER PUMP ON HIGH SETTING. NO ISSUES WERE DETECTED WITH THE OTHER 6 DEVICES. NO FIXTURE WAS USED TO FILL THE DEVICE, WHICH WAS STATIONED ON THE MIXING TABLE IN A VERTICAL POSITION. PER THE REPORT, THE PRODUCT WAS NOT STORED IN THE PRESENCE OF UV LIGHT. THE CUSTOMER DID NOT DETECT EVIDENCE OF A PRIOR HOLE IN THE RESERVOIR, WHICH WAS DESCRIBED AS BEING IN A FOOTED POSITION. NO EXTERNAL GLUE WAS OBSERVED ON THE RESERVOIR. THE RESERVOIR WAS ATTACHED TO THE POST. THE CUSTOMER USES THE PACKAGE INSERT FOR DIRECTION TO FILL THE DEVICE. A NEW DEVICE WAS FILLED TO REPLACE THE DAMAGED UNIT WITHOUT FURTHER EVENT. PRIOR TO FILLING THE 7 UNITS, THE BAXA PUMP HAD BEEN SET ON HIGH TO FILL UNSPECIFIED EMPTY BAGS WITH DEXTROSE. THERE IS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27604 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12H082

    Patients

    Seq Age Sex Outcome Treatment
    1