BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 2647858 · Received July 3, 2012

    Report

    Report Number
    2021710-2012-00063
    Event Type
    Injury
    Date Received
    July 3, 2012
    Date of Event
    June 7, 2012
    Report Date
    June 7, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, CAREFUSION SENT A LETTER VIA E-MAIL TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF (B)(4) 2012, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE USER FACILITY VIA E-MAIL. (B)(4). THE FISHER & PAYKER REP IN CONJUNCTION WITH A USER FACILITY REP DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS THAT THE STAFF HAD NOT REMOVED THE NON-HEATED PORTION OF THE PT CIRCUIT FROM THE CIRCUIT WHEN THEY REMOVED THE PT FROM THE WARMER. FISHER & PAYKEL RECOMMENDS REMOVING THE NON-HEATED PORTION OF THE PT CIRCUIT FROM THE PT CIRCUIT WHEN THE PT IS NOT IN A WARMER OR UNDER RADIANT HEAT. THE USER FACILITY REP STATED "THE PROBLEM DOES NOT APPEAR TO BE RELATED WITH THE [CAREFUSION] SIPAP UNIT OR THE [CAREFUSION] GENERATOR."

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED BY A CAREFUSION TECH SUPPORT SPECIALIST FROM AN E-MAIL FROM A CAREFUSION PRODUCT MANAGER. "I RECEIVED A CALL YESTERDAY FROM THE F&P REP, WHO WAS AT (B)(4) MEDICAL CENTER, TO ALERT ME TO A POSSIBLE PT INCIDENT CONNECTED TO THE USE OF A SIPAP UNIT. SINCE AN MR850 WAS ALSO INVOLVED, HE REPORTED THE POSSIBLE INCIDENT TO F&P. ACCORDING TO THE CLINICIAN I SPOKE TO ON THE PHONE, ALLEGEDLY A (B)(6) PT WAS PUT ON SIPAP WHILE STILL IN A WARMER. THE PT WAS REMOVED FROM THE WARMER AND KEPT ON SIPAP. THE PROBLEM SUPPOSEDLY AROSE BECAUSE THE NON-HEATED PORTION OF THE SIPAP CIRCUIT WAS NOT REMOVED. BECAUSE THAT PORTION IS UNHEATED, SUPPOSEDLY LOTS OF CONDENSATION OCCURRED IN THAT PIECE AND MADE ITS WAY TO THE SIPAP NASAL PRONGS. F&P HAS ROUTINELY RECOMMENDED TO THEM TO REMOVE THAT PORTION OF UNHEATED CIRCUIT WHEN A PT IS NOT IN A WARMER OR UNDER RADIANT HEAT. CONSEQUENTLY, IT IS ALLEGED BY THE CLINICIAN THAT THE EXCESS CONDENSATION THEN ENTERED THE PT'S AIRWAY, THROUGH THE NARES, AND CAUSED CLINICAL PROBLEMS WITH THE PT ENOUGH TO SUPPOSEDLY BRING ON AN EMERGENCY SITUATION BECAUSE THE PT'S SITUATION SIGNIFICANTLY DETERIORATED. ONCE THE PT WAS STABILIZED, HE/SHE WAS PUT BACK ON SIPAP AND THIS TIME THE UNHEATED PORTION OF THE CIRCUIT WAS NOT INSTALLED SINCE THE PT WAS NOT IN A WARMER OR UNDER RADIANT HEAT. THE CLINICIAN REPORTED THAT THIS TIME AROUND, WITH THE UNHEATED PORTION OF THE CIRCUIT REMOVED, CONDENSATION WAS NOT AN ISSUE AND THE PT WAS TREATED WITHOUT INCIDENT." THE FOLLOWING ADD'L INFO CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS COPIED BY A CAREFUSION TECH SUPPORT SPECIALIST FROM AN E-MAIL FROM A USER FACILITY REP. "AS STATED IN YOUR SUMMARY, THE PT APPEARED TO HAVE REACTED FROM EXCESSIVE CONDENSATION IN THE CIRCUIT. AT THIS TIME, THE PT CONTINUES TO CYCLE BETWEEN NASAL CANNULA AND SIPAP WITH MINIMAL ISSUES WITH CONDENSATION. THE PROBLEM DOES NOT APPEAR TO BE RELATED WITH THE SIPAP UNIT OR THE GENERATOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION INFANT FLOW SIPAP DRIVER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU Other F&AMP, PRT132 INFANT CONT FLOW BREATHING CIRCUIT| F&AMP, PMR850 HUMIDIFIER| CAREFUSION INFANT FLOW LP GENERATOR