BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 1548205 · Received November 19, 2009

    Report

    Report Number
    2021710-2009-00053
    Event Type
    Malfunction
    Date Received
    November 19, 2009
    Date of Event
    September 6, 2009
    Report Date
    November 16, 2009
    Manufacturer
    CAREFUSION 207, INC.
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY MEDWATCH REPORT CONTAINED THE CATALOG NUMBER OF A BOX OF 4 3100 B FILTERED PATIENT CIRCUITS. INCORRECT ENTRY: 16390-101 (BOXED OF 4 3100B FILTERED PATIENT CIRCUITS). CORRECT ENTRY: 16389-101 (SINGLE BAGGED 3100B FILTERED PT CIRCUIT). THE USER FACILITY DID NOT PROVIDE ANY PT OR DEVICE CODES ON THEIR USER FACILITY REPORT. (B)(4): THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE 3100B FILTERED PT CIRCUIT P/N 16389-101 RETURNED BY THE USER FACILITY AND WAS ABLE TO VERIFY THE REPORTED EVENT. AN INVESTIGATION PERFORMED BY THE CAREFUSION ENGINEERING DEPARTEMENT ON THE CIRCUIT P/N 16389-101 SINGLE PKG PATIENT CIRCUIT, AN INDIVIDUAL COMPONENT IN THE P/N 16390-101 PACKAGE OF 4, RESULTED IN EVIDENCE OF A 10% NON-WETTING SURFACE AREA RESULTING IN THE REPORTED "BREAKAGE." THIS WAS DETERMINED VIA VISUAL INSPECTION OF RETURNED PARTS. AN INTERNAL CORRECTIVE ACTION REQUEST (CAR) WAS INITIATED TO ADDRESS THIS ISSUE. PER THE CUSTOMER, THEY NO LONGER WANT TO USE THE FILTERED PT CIRCUITS P/N 16389-101, THEREFORE, REPLACEMENT UNFILTERED PATIENT CIRCUITS P/N 771383-102 WERE SENT TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] CALLED AND SAID THAT HE'S HAVING PROBLEMS WITH FILTERED CIRCUITS. HE SAID THAT HE HAS 2 CIRCUIT THAT HAVE THE LOT # 121406, PN-16390-101. HE SAID IT'S THE SAME PROBLEM AS BEFORE, THE ELBOW BETWEEN THE DUMP AND CONTROL CAP COMES LOOSE. I EXPLAINED TO HIM THAT IS AN OLDER LOT #, HE RECHECKED IT AND THAT'S WHAT IT SAYS. HE SAID THAT THEY ARE FROM THE REPLACEMENT BOX WE SENT THEM. HE SAID THAT HE WILL SEND ONE BACK, ONE THAT WAS NEVER USED ON A PT. HE SAID THAT THE OTHER ONE WAS ON A PT, HE SAID THAT THEY ENDED UP SWAPPING THE ENTIRE UNIT OUT. HE SAID THERE WAS "NO PT COMPROMISE." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION ON 10/22/2009: "TITLE: XXXXX. EVENT DESC: PATIENT ON 3100B HIGH FREQUENCY OSCILLATOR WITH A FILTERED CIRCUIT. PER RT, THE CIRCUIT WAS FOUND BROKEN AT THE TEE BETWEEN THE DUMP AND CONTROL VALVE ASSEMBLIES. THIS HAS BEEN A FREQUENT PROBLEM WITH THE FILTERED CIRCUIT ON THE 3100B. SENSORMEDICS IS AWARE OF THE PROBLEM." "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH CAI CIRCUIT, BREATHING (W CON, ADAP, Y PIE) CAI CAREFUSION 207, INC. NA 121406

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other