BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 2221263 · Received August 17, 2011

    Report

    Report Number
    2016493-2011-00476
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 4, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2011. (B)(4). METHOD: LOG REVIEW. THE CUSTOMER'S REQUEST FOR A LOG REVIEW FOR A POSSIBLE OVER SEDATION WAS COMPLETED. A REVIEW OF THE RETURNED PC UNIT AND PCA LOGS FOUND NO ISSUES WITH THE PROGRAMMING PARAMETERS. THE LOG REVIEW REVEALED A TOTAL OF 19 PCA DOSES WERE DELIVERED FOR A TOTAL OF 7.6ML. THE LOGS ALSO SHOWED THERE WERE SEVERAL PCA REQUESTS FROM THE PT THAT OCCURRED WITHIN THE LOCKOUT PERIOD. THE CAUSE OF THE CUSTOMER'S OVER SEDATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED AN EVENT LOG REVIEW REGARDING A PCA PT WHO BECAME OVER-SEDATED. ON (B)(6) 2011, THE PT RECEIVED SPINAL ANESTHESIA AND MULTIPLE IV MEDS FOR AN ABOVE THE KNEE AMPUTATION. AFTER SURGERY AND ADMINISTRATION OF IVP DILAUDID, THE PT WAS STARTED ON PCA AT 1642 WITH THE FOLLOWING ORDERS: DILAUDID 15MG/30ML, PCA ONLY, 0.2MG, LOCKOUT 10 MINS, 1 HOUR MAX OF 2MG/HR. THE PACU RN DOCUMENTED THE ORDERS AS "PCA ONLY 15MG/30ML, 0.2MG EVERY 10 MIN, 2MG EVERY 4 HOURS LOCKOUT". THE PT LEFT PACU ALERT AND WAS RECEIVED AT 1730 BY INTERMEDIATE UNIT, "AWAKE AND AGITATED, AND PAIN NOT UNDER CONTROL YET". PT WAS ORDERED TO HAVE BIPAP VENTILATION; ABGS WERE DRAWN AN HOUR LATER. AT 1858, THE PT WAS ASSESSED AS "DROWSY". AT 0022, THE SURGEON WAS CONTACTED REGARDING DECREASING LEVEL OF CONSCIOUSNESS AND RESPIRATORY RATE 7/MINUTE. THE PCA PUMP WAS DISCONTINUED AT 0030. THE RAPID ACTION TEAM WAS NOTIFIED. THE PT RECEIVED 3 DOSES OF NARCAN WITH MINIMAL TO NO RESPONSE AND WAS PLACED ON A CONTINUOUS NARCAN INFUSION. NARCAN WAS DISCONTINUED 15 HOURS LATER WHEN THE PT BECAME MORE ALERT, AND SHE WAS DISCHARGED TO THE NURSING HOME ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE MEA CAREFUSION CORP. 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ALARIS PC UNIT: SN (B)(4)| BIPAP VENTILATION| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PCA ADMINISTRATION SET: MODEL/LOT # UNK