BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 2001497 · Received February 25, 2011

    Report

    Report Number
    6000001-2011-01343
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW WAS CONDUCTED ON PRODUCT CODE: 2C1742K (BATCH NUMBER 10M011) WITH NO ABNORMALITY OBSERVED. (B)(4)

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE THE REPORTED CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND AN ASSIGNABLE CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF AN INTERMATE THAT WAS LEAKING. THE UNITS WERE PRE-FILLED BY (B)(4) AND CONTAINED PAMIDRONATE 90MG IN 250ML IN 0.9% NACL USP INJ.; ADMIXTURE CODE PX0242, LOT# 11A10CC0008. A REVIEW OF THE (B)(4) WORK SHEET INDICATED THAT THE ADMIXTURES WERE PREPARED AND UNITS WERE SHIPPED ACCORDING TO LOCAL PROCEDURES AND SPECIFICATIONS; NO LEAK WAS NOTED DURING PROCESSING AND PACKAGING. THE PROBLEM DID NOT OCCUR IMMEDIATELY AFTER FILL. THE DRUG WAS NOT FILTERED DURING COMPOUNDING. THE LOCATION OF THE LEAK IS UNKNOWN. THE BLUE WINGED LUER CAP AND FILL PORT CAP WERE SECURED AFTER FILLING AS PER TECHNICIAN WHO PREPARED THE ADMIXTURE. THE CUSTOMER COULD NOT IDENTIFY THE LOCATION OF THE LEAK. THE PROBLEM WAS NOTED PRIOR TO PRODUCT USE AND THERE WAS NO PATIENT INVOLVEMENT. SAMPLES WERE DISCARDED BY THE CUSTOMER. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 100, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10M011

    Patients

    Seq Age Sex Outcome Treatment
    1 PAMIDRONATE 90MG, NACL