BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11207469 · Received January 21, 2021

    Report

    Report Number
    2016493-2021-09598
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    November 24, 2020
    Report Date
    December 29, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B5, CORRECTION MADE TO THE PRODUCT GRID TO REFLECT THE NEW SUSPECT INSTRUMENT SN (B)(6) .

    Additional Manufacturer Narrative · 0

    SAMPLE INSPECTION: INSTRUMENT SEAL WAS OBSERVED PEELED BACK. ONE LATCH SEAR FINGER GRIPPER WAS OBSERVED SLIGHTLY BENT. BOTH IUI CONNECTORS WERE FOUND DULL. SECURITY RELEASE LATCH DID NOT MOVE BACK AND FORTH FREELY. ALL OTHER POSSIBLE REPLACEMENT PARTS WERE OBSERVED TO BE BD PARTS. BEZEL DATE CODE: SEPTEMBER 2017 LOG ANALYSIS RESULTS: RESULTS FROM A REVIEW OF THE PCU EVENT LOG IDENTIFIED A SECONDARY INFUSION OF POTASSIUM CI CENTRAL PROGRAMMED ON 24 NOVEMBER 2020 AT 6:35:19 PM AT A RATE: 87ML/H WITH A VTBI OF 87ML. THE VTBI WAS CHANGED TO 0.1ML AT 6:56:22 PM. THE SECONDARY INFUSION COMPLETED AND TRANSITIONED TO THE PRIMARY INFUSION AT 6:56:46 PM. THE DEVICE WAS CHANNELED OFF AT 7:08:33 PM AND REMOVED FROM THE SYSTEM AT 7:08:41 PM. TEST RESULTS: TIMED RATE ACCURACY TESTING PERFORMED ON THE SOURCE PUMP MODULE ATTACHED TO THE CUSTOMER¿S PCU, INFUSING WITH A RATE CONTROLLED SET FOUND THE PUMP MODULE DELIVERING FLUID WITHIN SPECIFICATION. TEST METHODS: ALARIS SYSTEM OVER INFUSION (DIR 10000360063) TEST METHOD 1503-001-006-R TIMED RATE ACCURACY TEST METHOD DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 03/01/2013. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SERIAL NUMBER (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT OF AN OVER INFUSION OF POTASSIUM CHLORIDE WAS NOT DETERMINED OR REPLICATED DURING TESTING. THE CUSTOMER PUMP MODULE DEMONSTRATED TO BE OPERATING AS INTENDED, IN SPECIFICATION. THE CUSTOMER¿S EXPERIENCE WITH A POTASSIUM CHLORIDE OVER INFUSION WAS NOT CONFIRMED DURING A REVIEW OF THE LOGS OR DURING THE INVESTIGATION TESTING PERFORMED. ¿ RESULTS FROM A REVIEW OF THE PCU EVENT LOG IDENTIFIED THE REPORTED POTASSIUM CHLORIDE AS A SECONDARY INFUSION PROGRAMMED ON 24 NOVEMBER 2020 AT 6:35:19 PM AT A RATE OF 87ML/H WITH A VTBI OF 87ML. THE VTBI WAS CHANGED TO 0.1ML AND THE SECONDARY INFUSION COMPLETED AND TRANSITIONED TO THE PRIMARY INFUSION AT 6:56:46 PM. THE DEVICE WAS THEN CHANNELED OFF AND REMOVED FROM THE SYSTEM. ¿ FUNCTIONAL TESTING PERFORMED, CONSISTING OF A TIMED RATE ACCURACY TEST ON THE RETURNED PUMP MODULE FOUND THE DEVICE IN GOOD WORKING CONDITION AND DELIVERING FLUID WITHIN SPECIFICATION. ¿ NO DISPOSABLE SET WAS RETURNED FOR THIS INVESTIGATION THEREFORE THE POSSIBILITY OF A CHECK VALVE FAILURE, LEADING TO BACKFLOW INTO THE PRIMARY BAG, COULD NOT BE ASCERTAINED. ¿ THE DEVICE WAS BEING USED FOR TREATMENT. SERVICE WILL BE INSTRUCTED TO REPLACE THE MECHANISM ASSEMBLY AS IT WAS DISASSEMBLED DURING THE INVESTIGATION. MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO CAD, THE SERVICE DEPOT, OR THE CUSTOMER. MANUFACTURING TESTS INVOLVE AN OCCLUDER SPRING TEST, AN X-RAY SPRING INSPECTION AND INSTALL OF NEW ONE-TIME USE TORQUE SCREWS WITH APPLIED TAMPER SEAL MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NURSE PROGRAMMED THE DRUG AS 17.4 MEQ POTASSUIM CHLORIDE (ORDER WAS FOR 17.4 MEQ/87 ML). THE PUMP STATED VOLUME TO BE INFUSED WAS 57.1MLS WHEN THERE WAS ACTUALLY NO MEDICATION LEFT IN BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NURSE PROGRAMMED THE DRUG AS 17.4 MEQ POTASSUIM CHLORIDE (ORDER WAS FOR 17.4 MEQ/87 ML). THE PUMP STATED VOLUME TO BE INFUSED WAS 57.1MLS WHEN THERE WAS ACTUALLY NO MEDICATION LEFT IN BAG.

    Additional Manufacturer Narrative · 1

    CONTINUED FROM PATIENT IDENTIFIER-DS. ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. PATIENT HAD FEBRILE NEUTROPENIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NURSE PROGRAMMED THE DRUG AS 17.4 MEQ (ORDER WAS FOR 17.4 MEQ/87 ML). THE PUMP STATED VOLUME TO BE INFUSED WAS 57.1MLS WHEN THERE WAS ACTUALLY NO MEDICATION LEFT IN BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107625 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR 8110| SYRTUBE,8015, THERAPY DATE (B)(6) 2020