BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA PLS II

    MDR report key: 3032824 · Received February 28, 2013

    Report

    Report Number
    9615050-2013-00290
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    November 6, 2012
    Report Date
    January 29, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K912928
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT NUMBER IS (B)(4). AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. AS INDICATED, THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH WAS RECEIVED DIRECTLY FROM THE USER FACILITY THAT STATED THE FOLLOWING: "PATIENT (B)(6) ON (B)(6) 2012 WAS BEING ADMINISTERED PAIN MEDICATION THROUGH A PCA PUMP. NURSING HAD TO CHANGE OUT THE PAIN MEDICATION SYRINGE. NURSING STAFF DID ENCOUNTER SOME DIFFICULTY IN GETTING A NEW SYRINGE INTO THE PCA PUMP. FOLLOWING THE INSERTION OF A NEW SYRINGE THE PATIENT WAS FOUND TO BE UNRESPONSIVE AND A CODE WAS CALLED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER CARE. IT WAS DETERMINED THAT THE PATIENT RECEIVED MORE THAN THE ORDERED DOSE OF PAIN MEDICATION. THE PCA PUMP WAS REMOVED FROM SERVICE AND EXAMINED ALONG WITH AN EVALUATION OF THE PROCEDURE FOLLOWED BY NURSING TO CHANGE OUT THE OLD SYRINGE FOR THE NEW ONE." UPON FURTHER QUERY THE FOLLOWING INFORMATION WAS PROVIDED THAT INDICATED THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. ON (B)(6) 2012 AT 1330, THE DEVICE WAS PROGRAMMED TO DELIVER DILAUDID 1 MG/ML, IN THE PCA ONLY MODE, WITH A 0.2 MG PCA DOSE, AND AN 8 MINUTE PATIENT LOCKOUT, AND THE DELIVERY WAS STARTED. ON (B)(6) 2012 AT AN UNSPECIFIED TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE EXPERIENCED UNSPECIFIED DIFFICULTY WHILE LOADING A NEW SYRINGE INTO THE DEVICE. AT 1815, THE CUSTOMER CONTACT REPORTED A FAMILY MEMBER FOUND THE PATIENT UNRESPONSIVE AND NOT BREATHING. AT THAT TIME, A CODE BLUE WAS CALLED. IT WAS REPORTED THE PATIENT HAD A PULSE. AT AN UNSPECIFIED TIME, THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. AT 1825 AND 1830, THE PATIENT WAS TREATED WITH NARCAN 0.2 MG I.V. PUSH AND UNSPECIFIED OXYGEN THERAPY WAS INITIATED. AFTER A REPORTED SHORT TIME, THE PATIENT BECAME RESPONSIVE AND WAS TALKING; HOWEVER, WAS LETHARGIC. AT THAT TIME, THE PATIENT'S BLOOD PRESSURE WAS 153/73 MMHG. THE CUSTOMER CONTACT REPORTED THAT 22 ML WERE LEFT IN THE 30 ML SYRINGE. AT AN UNSPECIFIED TIME, THE PATIENT UNDERWENT AN UNSPECIFIED CT SCAN. NO RESULTS WERE REPORTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. AT THAT TIME, THE PATIENT WAS TREATED WITH ADDITIONAL 0.2 MG OF NARCAN IVP FOR CONTINUED LETHARGY. AT 2200, IT WAS REPORTED THAT THE PATIENT WAS STARTED ON A CONTINUOUS NARCAN DELIVERY AT A RATE OF 0.2 MG/HR. AT THAT TIME, THE PATIENT'S RESPIRATORY RATE WAS 12-15 BREATHS/MIN, OXYGEN SATURATION 100 PERCENT ON 6 L VIA HIGH FLOW NASAL CANNULA, AND THE BLOOD PRESSURE WAS REPORTED AS STABLE. AT 2230, IT WAS REPORTED THAT NARCAN DELIVERY RATE WAS INCREASED TO A RATE OF 0.4 MG/HOUR. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT PATIENT'S RESPONSIVENESS RETURNED TO A REPORTED BASELINE AND THE NARCAN DELIVERY WAS DISCONTINUED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THE CUSTOMER CONTACT COULD NOT SPECIFY IF THE NURSE CLAMPED THE TUBING SET USING THE SLIDE CLAMP PRIOR TO CHANGING THE SYRINGE; HOWEVER, THE NURSES WERE RETRAINED TO CLOSING THE SLIDE CLAMP ON THE TUBING SET PRIOR TO REPLACING OR REMOVING THE PCA SYRINGE FROM THE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88961 PCA PLS II 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R DILAUDID: MFR UNK