BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11332529 · Received February 16, 2021

    Report

    Report Number
    2016493-2021-25227
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    January 16, 2021
    Report Date
    January 28, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT AN INFUSION OF PITOCIN WAS INFUSING AT A BOLUS RATE WITH NO ALARMS WAS NOT CONFIRMED IN THE LOGS; HOWEVER, TESTING REPLICATED A FAILURE WITH THE SEAR NOT FULLY ENGAGING THE ADMINISTRATION SAFETY CLAMP CAUSING UNREGULATED FLOW WITH NO ALARM. THE REVIEW OF THE PCU EVENT LOG RECORDED THE PCU RECEIVING A ¿REMOTE IV¿ FOR THE MEDICATION OXYTOCIN (DRUG ID 843) AT AN INFUSION RATE OF 2ML/HR. APPROXIMATELY ONE MINUTE AFTER THE START OF THE INFUSION THE PUMP ALARMS FOR ¿FLOW STOP OPEN¿ AND ¿INFUSOR DOOR OPEN¿ FOR TEN SECONDS. THE PCU THEN RECORDS A ¿DOOR CLOSED¿ AND THE INFUSION IS STARTED BY THE USER. THE INFUSION IS PAUSED AND STARTED BY THE USER AND IS THEN CHANNELED OFF. REVIEW OF THE PCU EVENT LOG COULD NOT DETERMINE IF AN UNREGULATED FLOW EVENT OCCURRED. RATE ACCURACY TESTING FOUND THE DEVICE DELIVERING IV FLUID IN SPECIFICATION. LATCH/SEAR TESTING WAS PERFORMED TO DETERMINE IF THE SEAR IS ENGAGING THE ADMINISTRATION SET SAFETY CLAMP. TESTING FOUND THAT SEAR DID FAIL TO ENGAGE THE CLAMP WITH NO AUDIBLE ALARM. DIMENSIONAL ANALYSIS OF THE SEAR FOUND THE SEARS MEASUREMENT IN SPECIFICATION. TESTING PERFORMED USING A KNOWN GOOD LATCH AND SEAR INSTALLED IN THE SOURCE PUMP MODULE. RESULTS FROM THE TEST FOUND THE KNOWN GOOD LATCH AND SEAR ENGAGING THE ADMINISTRATION SAFETY CLAMP. THERE WERE NO ALARMS OR OBSERVATION OF UNREGULATED FLOW. INSPECTION OF THE LATCH AND SEAR FOUND SOME DRIED FLUID AT THE BASE OF THE SEAR. INSPECTION OF THE SOURCE PUMP MODULE FOUND NO ANOMALIES. THE PROBABLE CAUSE IS BELIEVED TO BE THE RESULT OF THE SEAR NOT ENGAGING THE ADMINISTRATION SET SAFETY CLAMP WHEN THE DOOR IS OPENED. DEVICE HISTORY REVIEW: REVIEW OF THE SOURCE PUMP MODULE S/N (B)(6) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 12/17/2014. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 02/15/2021 AND INDICATED THAT THIS DEVICE HAS BEEN PREVIOUSLY RETURNED FOR SERVICE FOR AIL AND PRESSURE SENSOR ISSUES. SERVICE WAS PERFORMED ON 29SEP2016, THE BEZEL AND AIL ASSEMBLY WAS REPLACED. REVIEW OF THE PRODUCTION FAILURE RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH PRESENT. THE FAILURE RECORD SHOWED NO PRODUCTION FAILURE RECORDS WERE OPENED FOR THE SOURCE DEVICE. THE REVIEW OF COMPLAINT HISTORY RECORDS WAS PERFORMED FOR THE RETURNED SOURCE DEVICES (S/N (B)(6)) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A PATIENT INCIDENT INVOLVING THREE (3) DEVICES. IT WAS REPORTED THAT WHEN STARTING IV PITOCIN THRU THE IV PUMP WITH 2 PEOPLE (TWO NURSE CRITICAL DRUG VERIFICATION), THE PUMP WAS REVIEWED AND CONFIRMED TO BE PROGRAMMED AT 2 MU (MILLIUNITS)/HOUR, PER THE DOCTOR'S ORDER. WITHIN 1 MINUTE, THE NURSES AT BEDSIDE CONFIRMED AGAIN THAT THE PUMP WAS SET AT 2MU/HR BUT IT WAS ACTUALLY INFUSING AT A BOLUS RATE. IT WAS NOTED THAT NO ALARM SOUNDED. THE IV WAS STOPPED AND PUMPS WERE CHANGED. THE MEDICATION BOLUS INFUSION CAUSED THE FETAL HEART RATE TO DROP. ALTHOUGH REQUESTED, NO FURTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. ALTHOUGH REQUESTED, NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT INCIDENT INVOLVING THREE (3) DEVICES. IT WAS REPORTED THAT WHEN STARTING IV PITOCIN THRU THE IV PUMP WITH 2 PEOPLE (TWO NURSE CRITICAL DRUG VERIFICATION) , THE PUMP WAS REVIEWED AND CONFIRMED TO BE PROGRAMMED AT 2 MU (MILLIUNITS)/HOUR , PER THE DOCTOR'S ORDER. WITHIN 1 MINUTE, THE NURSES AT BEDSIDE CONFIRMED AGAIN THAT THE PUMP WAS SET AT 2MU/HR BUT IT WAS ACTUALLY INFUSING AT A BOLUS RATE. IT WAS NOTED THAT NO ALARM SOUNDED. THE IV WAS STOPPED AND PUMPS WERE CHANGED. THE MEDICATION BOLUS INFUSION CAUSED THE FETAL HEART RATE TO DROP. ALTHOUGH REQUESTED, NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229465 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 8015,8100,(2)PRI TUBING, TD (B)(6) 2021.| 8015,8100,(2)PRI TUBING,TD (B)(6) 2021