BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2141707 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-08972
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPB
    PMA / PMN Number
    K860746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. DURING THE INSPECTION, NO PARTICULATE MATTER WAS OBSERVED INSIDE THE FLUID PATH. THE REPORTED CONDITION WAS NOT CONFIRMED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A 60" MICRO-VOLUME EXTENSION SET IN WHICH PARTICULATE MATTER WAS IDENTIFIED IN THE TUBING. ACCORDING TO THE REPORT, THE PATIENT STATED "THERE ARE TWO LITTLE WHITE PIECES IN THE TUBING THAT ARE CAUSING THE PUMP TO ALARM." THE EVENT OCCURRED IN THE PATIENT'S HOME, WHERE SHE WAS BEING TREATED FOR PULMONARY ARTERIAL HYPERTENSION (PAH). THE PATIENT REPORTED AN UNSPECIFIED OCCLUSION ALARM WHILE INFUSING REMODULIN USING A CRONO 5 PUMP. IT IS UNKNOWN IF THE TUBING WAS ACTUALLY OCCLUDED. THE PATIENT CHANGED THE TUBING WHEN THE ALARM OCCURRED (2 TIMES) AND CONTINUED TREATMENT WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS FILTER, INFUSION LINE FPB BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 REMODULIN| CRONO 5 PUMP