BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 2895342 · Received November 14, 2012

    Report

    Report Number
    2016493-2012-00490
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    August 10, 2012
    Report Date
    October 16, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DECLINED AN INVESTIGATION BY CAREFUSION CUSTOMER ADVOCACY. THE CUSTOMER STATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE THE DEVICE WAS PLACED BACK INTO SERVICE AFTER BEING EVALUATED BY THEIR BIOMED DEPT. TIP SHEETS FOR CLEANING THE DEVICE AND A LIST OF RECOMMENDED CLEANERS WERE SENT TO THE CUSTOMER. DISCUSSED WITH CUSTOMER THAT ORGANOSOL AND CAVICIDE ARE NOT RECOMMENDED CLEANERS.

    Description of Event or Problem · 1

    CUSTOMER'S MEDWATCH REPORT RECEIVED. PER REPORT: "PT HAD IV FLUIDS WITH PCA (PT CONTROLLED ANALGESIA) CONTINUOUS AND AN ANTIBIOTIC RUNNING. PT STARTED HAVING INCREASED PAIN AND MOTHER OF PT REQUESTED THAT THE NURSE CALL THE PHYSICIAN TO HAVE HIS PAIN MEDICATION INCREASED. NURSE OBTAINED THE ORDER FROM THE HEM/ONC TEAM TO INCREASE IT. WHEN TWO RNS WENT INTO THE PT'S ROOM TO CHANGE THE PCA SETTINGS THEY FOUND THAT THE VOLUME INFUSER BRAIN WAS ON AND THE FLUIDS WERE RUNNING ON THE RIGHT SIDE OF THE PUMP, BUT THE PCA AND PT'S SYRINGE PUMP WITH THE ANTIBIOTIC WAS TURNED OFF. BOTH RNS DETERMINED FROM THE HISTORY ON THE PUMP THAT IT HAD BEEN OFF FOR APPROX 1 HOUR AND 45 MINUTES. WHEN ONE OF THE RNS SQUEEZED THE BRAIN AND THE PCA PUMP TOGETHER, IT WOULD LIGHT UP. AS SOON AS THE OTHER RN WOULD LET OFF, IT WOULD SHUT OFF AGAIN. PHYSICIAN WAS NOTIFIED AND ORDER RECEIVED FOR ONE TIME BOLUS. WE HAVE HAD THIS TYPE OF ISSUE WITH THIS DEVICE PREVIOUSLY; HOWEVER, WE ARE NOT SEEING A TREND. THE PUMPS ARE CLEANED FIRST WITH ORGANOSOL AND THEN WITH CAVICIDE. STAFF THAT CLEANS THE EQUIPMENT USES A TOOTHBRUSH ON THE METAL CONNECTIONS TO ENSURE THAT THEY ARE CLEAN AND FREE FROM SCALE/DEPOSITS. "THIS PARTICULAR PCA HAD A NEW BATTERY REPLACED IN THE SPRING AND HAS PASSED ALL OF ITS PREVENTATIVE MAINTENANCE CHECKS. THE MOST RECENT PREVENTATIVE MAINTENANCE CHECK ON THE PCA WAS PERFORMED APPROX 3 MONTHS BEFORE THE EVENT. PER BIOMED, WE HAVE HAD NO TRENDS WITH DEVICE CONNECTIONS. BIOMED BELIEVES THAT THE DEVICE MAY NOT HAVE BEEN PLUGGED IN OR CONNECTED PROPERLY TO THE BRAIN. BIOMED STAFF WERE UNABLE TO REPRODUCE THE PROBLEM AND HAS RELEASED THE PCA UNIT BACK INTO USE. THIS INCIDENT CAUSED TEMPORARY HARM TO THE PT AND REQUIRED INTERVENTION. HOWEVER, SINCE INCIDENT, PT HAS BEEN DISCHARGED HOME." MEDICATION INFUSING: NALBUPHINE. THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention MODEL/LOT #UNK| ALARIS SYRINGE MODULE ADMINISTRATION SET| ALARIS SYRINGE MODULE, SN (B)(4)| ALARIS PCA ADMINISTRATION AET, MODEL/LOT #UNK| ALARIS PC UNIT, SN (B)(4)