BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE

    MDR report key: 2804694 · Received October 17, 2012

    Report

    Report Number
    2016493-2012-00438
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 17, 2012
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. TWO OVER INFUSIONS WERE REPORTED; THIS REPORT IS FOR THE FENTANYL INFUSION. REFERENCE MFG REPORT NUMBER 2016493-2012-00432 (CAREFUSION INTERNAL REPORT (B)(4)) FOR THE REPORT OF THE EPINEPHRINE OVER INFUSION. THE REPORT OF AN OVER INFUSION OF FENTANYL DUE TO A PT WEIGHT ERROR WAS CONFIRMED IN THE PC UNIT EVENT LOG. A REVIEW OF THE LOG INDICATES THAT THE SYSTEM HAD BEEN IN USE SINCE IT WAS INITIALLY POWERED ON AT 10:15 A.M ON (B)(6) 2012 WITH TWO MODULES ATTACHED. THE PT WEIGHT WAS ENTERED AS (B)(6) AT 12:31 P.M ON (B)(6) 2012 WHEN THE USER PROGRAMMED THE DRUG RANITIDINE. BOTH MODULES WERE USED INTERMITTENTLY; AT 6:25 P.M ON (B)(6) 2012, THE USER BEGAN TO POWER DOWN THE SYSTEM, AND DURING THE POWER DOWN CYCLE PRESSED THE 2 KEY WHICH INTERRUPTED THE POWER DOWN SEQUENCE. THE SYSTEM REMAINED ON BUT NOT IN USE AND REMAINED IN THIS STATE FOR MORE THAN 20 HOURS. AT 5:04 P.M ON (B)(6) 2012, FENTANYL WAS PROGRAMMED. THERE WAS NO OPTION TO SELECT ¿NEW PATIENT¿ AT THIS TIME BECAUSE THE DEVICE HAD NEVER BEEN FULLY POWERED DOWN. THE FENTANYL INFUSION WAS PROGRAMMED WITH THE EXISTING PATIENT WEIGHT OF (B)(6). THE CORRECT PATIENT WEIGHT WAS REPORTED TO BE (B)(6). THE PT WEIGHT WAS CHANGED FROM (B)(6) TO (B)(6) BY THE USER AT 8:11 AM ON (B)(6) 2012. THE SYSTEM REMAINED IN USE UNTIL (B)(6) 2012 AT 1:31 A.M WHEN IT WAS SHUT OFF. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE WAS DETERMINED TO BE A PROGRAMMING ISSUE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A PROGRAMMING ERROR THAT RESULTED IN AN OVER-INFUSION OF BOTH EPINEPHRINE AND FENTANYL ON A CRITICALLY ILL (B)(6), FEMALE INFANT FOLLOWING CARDIAC SURGERY. THE BABY WAS IN THE OPERATING ROOM ON (B)(6) 2012 UNTIL ABOUT 2:45 P.M. SHE WAS ON MULTIPLE DRIPS VIA SYRINGES RUNNING ON PUMP MODULES ON 3 DIFFERENT PCUS. THE PT HAD AN RA (RIGHT ATRIAL) LINE AND A MEDS LINE. REPORTEDLY, THE EPINEPHRINE DRIP WAS STARTED AT ABOUT 3:00 P.M. AND THE FENTANYL DRIP AT ABOUT 5 P.M. BOTH THE EPINEPHRINE AND FENTANYL WERE WEIGHT BASED INFUSIONS. THE INFUSIONS WERE TITRATED UP AND DOWN THROUGHOUT THE NIGHT. THE NEXT MORNING AT ABOUT 7:00 A.M TO 8:00 A.M., THE DAY NURSE DISCOVERED THAT THE PT¿S WEIGHT HAD BEEN ENTERED INCORRECTLY AS (B)(6), INSTEAD OF (B)(6). ALTHOUGH IT IS NOT KNOWN WHAT ROLE, IF ANY, THE OVER-INFUSION EVENTS PLAYED, THE PT DIED SEVERAL DAYS LATER. THE CUSTOMER IS REQUESTING AN EXPEDITED EVENT LOG REVIEW AND NEEDS TO KNOW THE TIME AND DATE THE PT WEIGHT OF (B)(6) WAS ENTERED INTO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYRINGE MODULE FRN CARDINAL HEALTH 303, INC. 8110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL/LOT UNK| SN - (B)(4)| ALARIS PUMP MODULE ADMIN SET| MODEL/LOT UNK| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNITS| SN - (B)(4)| SN- (B)(4)| ALARIS SYRINGE MODULE ADMIN SET| SN- (B)(4)| ALARIS SYRINGE MODULES: