BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-SIPHON PCA EXTENSION SET

    MDR report key: 1941565 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06379
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K880733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4)-BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE OF AN ANTI-SIPHON PCA EXTENSION SET IN WHICH LEAKING WAS OBSERVED AT THE SITE BETWEEN THE SYRINGE AND THE PCA TUBING DURING USE ON A FEMALE PATIENT. THE SET WAS USED WITH A PCA II PUMP, (B)(4). THE SET WAS CHANGED WHEN THE PROBLEM WAS DISCOVERED AND TREATMENT WAS CONTINUED WITHOUT FURTHER INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE REPORT AND THE NAME OF THE CLINICIAN WHO REPORTED THE CONDITION IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-SIPHON PCA EXTENSION SET PUMP, INFUSION FRN BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 PCA II PUMP (B)(4), UNKNOWN SYRINGE