BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8341295 · Received February 14, 2019

    Report

    Report Number
    2016493-2019-00151
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    October 29, 2018
    Report Date
    January 21, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    REMAINDER OF PATIENT¿S DELIVERY AND HOSPITALIZATION WAS WITHOUT INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PITOCIN INFUSION PROGRAMMED AT A RATE OF 1MILLIUNIT/MIN FREE FLOWED WHILE INDUCING LABOR, EVEN THOUGH THE DEVICE WAS PROGRAMMED CORRECTLY. THE INFUSION STARTED AT 0912; AFTER VERIFYING THE MEDICATION WITH 2 RN'S, THE NURSE NOTED THAT THE PITOCIN WAS "BOLUSING." THE INFUSION WAS IMMEDIATELY STOPPED AND THE PHYSICIAN NOTIFIED. THE PATIENT RECEIVED A LR BOLUS AND THE PITOCIN WAS TO BE HELD FOR 1 HR. AT 1007 THE PITOCIN WAS RESTARTED AT 1007 AT A RATE OF 1 MILLIUNIT/MIN. IT WAS REPORTED THAT THE PATIENT¿S DELIVERY HAD NO CHANGE IN PAIN, CONTRACTIONS, ABDOMEN SOFT TO PALPATION AND HOSPITALIZATION WAS WITHOUT INCIDENT; NO HARM WAS REPORTED. THE BIOMED PERFORMED A VISUAL INSPECTION, SEVERAL FUNCTIONAL CHECKS AND A FULL CHANNEL CALIBRATION; NO DISCREPANCIES WERE NOTED. ALTHOUGH REQUESTED, THERE WAS NO FURTHER INFORMATION OR DETAILS PROVIDED BY THE CUSTOMER. THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. PATIENT. RECEIVING PITOCIN - PRESUMING THAT THE PATIENT WAS FEMALE. PATIENT DEMOGRAPHICS REQUESTED HOWEVER NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PITOCIN INFUSION WAS PROGRAMMED AT A RATE OF 1 MILLIUNIT/HR. AFTER VERIFYING THE MEDICATION WITH 2 RN'S, IT WAS NOTED THAT THE PITOCIN WAS FREE FLOWING AFTER THE RATE OF 1 MILLIUNIT/HR ON THE DEVICE WAS INITIATED. THE INFUSION WAS IMMEDIATELY STOPPED AND THE DOCTOR WAS NOTIFIED. THE EVENT OCCURRED IN LABOR AND DELIVERY. THE CUSTOMER DID NOT INDICATE PATIENT HARM. THE BIOMED PERFORMED A VISUAL INSPECTION, FUNCTIONAL CHECKS SEVERAL TIMES AND A FULL CHANNEL CALIBRATION. IT WAS STATED BY BIOMED THAT A "SUCCESSFUL FUNCTIONAL CHECK PERFORMED FOLLOWING CALIBRATION WITH NO DISCREPANCIES NOTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131987 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R PRI TUBING, LR BAG| PRI TUBING,8015, THERAPY DATE 10/29/18