BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11100703 · Received December 31, 2020

    Report

    Report Number
    2016493-2020-79915
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Report Date
    December 3, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION: THE EVENT ADMINISTRATION SET WAS NOT RETURNED AND COULD NOT BE INSPECTED. LVP (B)(6) THE DEVICE WAS RECEIVED WITH INSTRUMENT SEAL MISSING. THE RIGHT (MALE) IUI WAS OBSERVED WITH DRIED FLUID AND DAMAGED ISOLATION RIBS. THE LEFT (FEMALE) IUI WAS OBSERVED WITH DRIED FLUID AND CORROSION. PLATEN ASSEMBLY, POST, HINGE, PINS, SPRINGS, AND BUTTONS ARE ALL INTACT AND DID NOT INTERFERE WITH THE DOOR OPERATION. LATCH SEAR ARE INSTALLED PROPERLY AND DID NOT INTERFERE WITH THE DOOR OPERATION. THE PUMP MODULE WAS OBSERVED WITH MISSING RUBBER FEET. ALL PARTS INSPECTED ARE MANUFACTURED BY BD. BEZEL WAS DISASSEMBLED AND OBSERVED IN GOOD CONDITION (DATE CODE: MAY 2018) LOG ANALYSIS RESULTS: THE CUSTOMER DID NOT PROVIDE AN EVENT DATE BUT REPORTED THE ISSUE TO BD ON 3 DECEMBER 2020. REVIEW OF THE SUSPECT DEVICE ERROR LOG SHOWED NO RECENT ERRORS WERE RECORDED. REVIEW OF THE SUSPECT DEVICE EVENT LOG SHOWED, PRIOR TO THE ISSUE BEING REPORTED TO BD, THE SUSPECT DEVICE WAS ATTACHED TO PCU 15305512 AND WAS IN USE ON (B)(6) 2020. THE REPORTED INFUSION PARAMETERS COULD NOT BE CONFIRMED DURING LOG REVIEW. TEST RESULTS: LVP (B)(6) TIMED RATE ACCURACY TESTING (DIR 10000360036) WAS PERFORMED USING A TEST ADMINISTRATION SET, SOURCE DEVICE (B)(6) AND TEST PCU TO DETERMINE IF THE SYSTEM IS DELIVERING FLUID IN SPECIFICATION. RESULTS INDICATE THAT THE SYSTEM WAS OPERATING WITHIN SPECIFICATION. SEE APPENDIX FOR RESULTS. SEAR FUNCTIONALITY TESTING WAS PERFORMED USING THE RETURNED SYSTEM AND TEN (10) NEW ADMINISTRATION SETS. THE RESULTS INDICATE THE SEAR DID NOT CONSISTENTLY ENGAGED THE SAFETY CLAMP WHEN THE DOOR WAS OPENED. TEST METHOD INFORMATION: 1503-001-029-R OVER INFUSION TEST METHOD (DIR 10000360063) 1503-001-006-R RATE ACCURACY TEST METHOD (DIR 10000360036) DEVICE HISTORY REVIEW: LVP (B)(6) A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 08/13/2018. 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 SOURCE DEVICE LVP SN 15294938 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 SOURCE DEVICE LVP (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 WAS NOT IDENTIFIED. INVESTIGATION CONCLUSION: THE CUSTOMER¿S COMPLAINT OF AN OVER INFUSION WAS NOT REPRODUCED. ¿ REVIEW OF THE SUSPECT DEVICE ERROR LOG SHOWED NO RECENT ERRORS WERE RECORDED. ¿ REVIEW OF THE SUSPECT DEVICE EVENT LOG SHOWED, REPORTED INFUSION PARAMETERS COULD NOT BE CONFIRMED DURING LOG REVIEW. PRIOR TO THE ISSUE BEING REPORTED TO BD, THE MOST RECENT PROGRAMMED INFUSION WAS ON 12 OCTOBER 2020 AT A RATE OF 50 ML/HR. ¿ DISASSEMBLY OF THE PUMPING MECHANISM SHOWED NO ANOMALIES ¿ TESTING SHOWED THE DEVICE WAS DELIVERING FLUIDS WITHIN SPECIFICATION. ¿ THE EVENT ADMINISTRATION SET WAS NOT RETURNED FOR INVESTIGATION ¿ THE DEVICE WAS BEING USED FOR TREATMENT PURPOSES. NOTE: THE PUMPING MECHANISM WAS DISASSEMBLED DURING THE INTERNAL INSPECTIONS. MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO CAD, 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. THE SERVICE DEPOT WILL REPLACE THE BEZEL ASSEMBLY BEFORE RETURNING TO THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OVER INFUSION OF KYPROLIS OCCURRED ON A PATIENT. THE INTENDED PROGRAMMING RATE WAS 100MG IN 160ML FOR 30 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    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. ALTHOUGH REQUESTED, PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVER INFUSION OF KYPROLIS OCCURRED ON A PATIENT. THE INTENDED PROGRAMMING RATE WAS 100MG IN 160ML FOR 30 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564169 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 PRI TUBING, 8015, TD UNK| PRI TUBING, 8015, TD UNK