BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION SET 102", ANTI-SIPHON

    MDR report key: 1901795 · Received November 17, 2010

    Report

    Report Number
    6000001-2010-04950
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K880733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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): ADDITIONAL INFORMATION. THE SAMPLE WAS RECEIVED FOR EVALUATION ON (B)(4) 2011. AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED THE TUBING WAS CUT AND THE MICROBORE WINGED FEMALE LUER LOCK WAS DAMAGED. THE SAMPLE WAS THEN SUBMITTED FOR AN UNDERWATER LEAK TEST AND THE SAMPLE FAILED. THE REPORTED CONDITION WAS CONFIRMED. THE CONDITION OCCURRED DURING THE PACKAGING PROCESS; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. A BATCH REVIEW COULD NOT BE PERFORMED 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A COMBINATION SET - 102" ANTI-SIPHON IN WHICH THE "SET SPLIT AND LEAKED MEDICATION ALL OVER THE FLOOR." ACCORDING TO THE REPORTER THE TUBING ITSELF SPLIT; HOWEVER, IT IS UNKNOWN WHERE EXACTLY ON THE SET THE SPLIT OCCURRED. IT IS UNKNOWN WHAT MEDICATION WAS BEING DELIVERED, BUT IT WAS NOT CHEMOTHERAPY OR ANY OTHER BIOHAZARDOUS DRUG. THE SET WAS BEING USED WITH AN UNKNOWN COLLEAGUE PUMP. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBINATION SET 102", ANTI-SIPHON PUMP, INFUSION FRN BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1