BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-SIPHON PCA EXTENSION SET

    MDR report key: 1979422 · Received February 4, 2011

    Report

    Report Number
    6000001-2011-00671
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K880733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TO BAXTER AN ANTI-SIPHON PCA EXTENSION SET IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, THE "TUBING ALLOWED AIR INTO MAINTENANCE IV LINE WHERE THE PCA WAS PLUGGED IN" WHILE ATTEMPTING TO INFUSE AN UNKNOWN NARCOTIC. AFTER EXAMINATION OF THE SET, IT APPEARED AS IF THE TIP HAS BROKEN OFF. THE SET WAS CONNECTED TO A BAXTER PCA II PUMP AT THE TIME OF THE INCIDENT. THE CONDITION OCCURRED DURING PATIENT USE. IT IS UNKNOWN HOW LONG INTO THE INFUSION THE CONDITION WAS NOTICED; HOWEVER, THE AIR WAS NOTICED BEFORE IT REACHED THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE BRAND NAME OF HIS SET IS - ANTI-SIPHON PCA EXTENSION SET. PRODUCT CODE - FRN. COMMON DEVICE NAME - PUMP, INFUSION. MANUFACTURER NAME - BAXTER HEALTHCARE -(B)(4). CATALOG NUMBER - 2L3508. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE SET WAS USED WITH A BAXTER PCA II PUMP - DATE: (B)(6) 2011. (B)(4). THE FDA 510K NUMBER FOR THIS SET IS K880733. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. 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. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER AN UNKNOWN BAXTER IV TUBING IN WHICH "TUBING ALLOWED AIR INTO MAINTENANCE IV LINE WHERE THE PCA WAS PLUGGED IN." IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS A PATIENT INVOLVED; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 BAXTER PCA II PUMP