BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    MDR report key: 1943221 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06523
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEA
    PMA / PMN Number
    K051253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE USED PATIENT CONTROL MODULE (PCM) DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "DIFFICULT TO INFLATE/SOLUTION RUNS STRAIGHT THROUGH" WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE DEVICE FOUND NO SIGNS OF PHYSICAL DEFECT OR ABNORMALITY. A FUNCTIONAL TEST WAS SUBSEQUENTLY PERFORMED ON THE DEVICE. DURING TESTING, NO EVIDENCE OF DEFECT WAS DETECTED. THE SOLUTION RETAINED WITHIN THE RESERVOIR AFTER BEING FILLED. SOLUTION ONLY CAME OUT OF THE LUER WHEN THE WHITE BUTTON WAS PRESSED. BASED ON THE EVALUATION FINDINGS, THE DEVICE PERFORMED AS EXPECTED. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE 2ML PATIENT CONTROL MODULE DEVICE WAS DIFFICULT TO INFLATE. ACCORDING TO THE REPORT, THE SOLUTION "WENT STRAIGHT THROUGH" DURING FILLING. THE MODULE WAS CHANGED TO A NEW ONE. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON PUMP, INFUSION, PCA MEA BAXTER HEALTHCARE - IRVINE 09M058

    Patients

    Seq Age Sex Outcome Treatment
    1