BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1476139 · Received September 10, 2009

    Report

    Report Number
    2021710-2009-00032
    Event Type
    Malfunction
    Date Received
    September 10, 2009
    Date of Event
    June 11, 2009
    Report Date
    September 10, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ALLEGED FAULTY 3100B FILTERED PATIENT CIRCUITS WERE RECEIVED IN SEALED BIO-HAZARD BAGS AND IN A BOX SEALED WITH BIO-HAZARD TAPE. THE 3100B FILTERED PATIENT CIRCUITS WERE DEEMED A BIOHAZARD AND REQUIRED BIOHAZARD HANDLING/DISPOSAL. THUS THE 3100B FILTERED PATIENT CIRCUITS (P/N 16389-102) WERE SCRAPED AND NOT EVALUATED. WE HAVE AN ONGOING INTERNAL INVESTIGATION RELATED TO THE 3100B FILTERED PATIENT CIRCUITS (P/N 16389-102) AND WE WILL SUBMIT A FOLLOW UP MEDWATCH REPORT ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] CALLER AND HE STATED THAT THEY HAD ANOTHER 3100B CIRCUIT THAT FAILED. (B)(4). LOT# 050409. IT WAS ON A PATIENT AT THE TIME AND THE CONNECTION BETWEEN DUMP AND CONTROL WAS LOOSE RIGHT WHERE IT SHOULD ATTACH TO THE CONTROL VALVE. HE SAID THAT THEY JUST KEPT HAVING PROBLEMS BEING ABLE TO HOLD THE MAP. THEY TRIED TO SECURE IT WITH TAPE, BUT NOTHING WOULD HELP. HE STATES THAT THERE WAS NO PATIENT COMPROMISE. THEY ENDED UP SWAPPING THE UNIT OUT AND GETTING A REGULAR NON FILTERED HEATED WIRE CIRCUIT BECAUSE THAT'S ALL THEY HAVE. HE WOULD LIKE TO SEND THIS CIRCUIT IN FOR EVALUATION ALSO. HE SAID THAT THE CIRCUIT HAS BEEN CLEANED AND IS DOUBLE BAGGED." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CARDINAL HEALTH (B)(4) FROM THE FDA AND THEN FORWARDED TO CARDINAL HEALTH 2007, INC ON 08/12/2009. "EVENT DESC: HFOV CIRCUIT WAS NOT STAYING TOGETHER AND WAS FREQUENTLY COMING APART. THIS SITE OF THE DISCONNECTION WAS AT THE T PIECE BETWEEN THE RED AND GREEN VALVES. CIRCUIT HUMIDIFIER WATER WAS LEAKING AND MAP'S UNABLE TO STAY AS SET DUE TO LOOSE CONNECTION. HFO VENT AND CIRCUIT WERE SWITCHED TO A NEW ONE. DEFECTIVE CIRCUIT WAS TAKEN TO BIOMED. BIOMED ANALYSIS REVEALED THE CONTROL CAP POPPED OFF DURING INSTALLATION. IN ADDITION, THE TEE ADAPTER BETWEEN DUMP CAP/DIAPHRAGM HOUSING AND CONTROL CAP/DIAPHRAGM HOUSING POPPED OFF DURING CIRCUIT INSTALL. NO STRESS PLACED ON THE AREA DURING INSTALL". "DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO". "WHAT WAS THE ORIGINAL INTENDED PROCEDURE? COUGH, FEVER, NAUSEA/VOMITING, RESPIRATORY DISTRESS REQUIRING INTUBATION." "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)". (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS CAI ANESTHESIA BREATHING CIRCUIT CAI CARDINAL HEALTH 207, INC. NA 050409

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR (B)(4)| LOT#: NA,| CARE FUSION HEALTHCARE CARDINAL HEALTH| SENSORMEDICS 3100B| VENTILATOR, HIGH FREQUENCY OSCILLATORY| MODEL #: 3100B| AGE OF DEVICE: 4 YRS| CATALOG #: NA,| OTHER #: NA