BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4213869 · Received August 14, 2014

    Report

    Report Number
    2016493-2014-00385
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Report Date
    July 3, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINT OF A BROKEN SEAR WAS CONFIRMED. THE CUSTOMER RETURNED THREE PUMP MODULES AND 9 LATCH ASSEMBLIES FOR INVESTIGATION. THIS REPORT IF FOR PUMP MODULE SN (B)(4). LOG ANALYSIS OF PUMP MODULE SN (B)(4) FOUND THAT THE PUMP MODULE WAS LAST USED ON (B)(6) 2014 AT 2:38 AM AND WAS INFUSING AT A RATE OF 133 ML/HR WITH A VTBI OF 200 ML. THE DEVICE EXPERIENCED THREE FLO-STOP OPEN ALARMS DURING THE INFUSION BEFORE BEING POWERED OFF AT 2:39 AM. INSPECTION OF THE RETURNED PRODUCT FOUND DAMAGE TO THE SEARS, INCLUDING SOME THAT WERE SPLIT DOWN THE MIDDLE BETWEEN THE TWO LEGS, SOME WITH THE RIGHT LEG BROKEN AND SOME WITH BOTH LEGS BROKEN. DRIED RESIDUE (BROWN IN COLOR) WAS ALSO OBSERVED ON MANY OF THE RETURNED SEARS. SOME OF THE BROKEN SEARS WERE FOUND OT HAVE AN IMPACT MARK NEAR THE EDGE OF THE LEFT LEG INDICATING IT HAD BEEN HYPER EXTENDED BEYOND THE NORMAL RANGE OF MOTION OF THE TORSION SPRING HITTING THE SEAR STOP. IT IS POSSIBLE THAT THIS WAS CAUSED BY THE DEVICE DOOR BEING SHUT AGAINST A STUCK SEAR RESULTING IN THIS MARK. INSPECTION OF THIS DEVICE SHOWED THE SEAR CRACKED THROUGH NEAR THE END OF THE TORSION SPRING WITH BOTH LEGS PRESENT, AND AN IMPACT MARK ON THE LEFT LEG INDICATING IT HAD BEEN HYPEREXTENDED. TESTING OF THE RETURNED PUMP MODULE WITH A TEST ADMINISTRATION SET INSTALLED CONFIRMED A "SAFETY CLAMP OPEN/CLOSE DOOR" ALARM. NO UNREGULATED FLOW WAS OBSERVED. THE DOOR WAS OPENED AND CLOSED MULTIPLE TIMES; HOWEVER, NO FREE FLOW CONDITIONS WERE OBSERVED. THE SERA PROPERLY CLOSED THE FLOW STOP AS REQUIRED AFTER EACH ATTEMPT. THE CUSTOMER REPORTED THAT THEIR DEVICES ARE CLEANED WITH CAVI-WIPES. REVIEW OF THE MATERIAL SAFETY DATA SHEETS FOR CAVI-WIPES DETERMINED THAT THE LATEST CHANGE TO THE FORMULATION OCCURRED IN 2012 AND CONTAINS TWO CHEMICALS THAT ARE ON THE ALARIS SYSTEM CLEANING PRODUCT GUIDELINES "DO NOT USE" LIST: ETHYLENE GLYCOL MONOBUTYL ETHER AND DIISOBUTYLPHENOXYETHOXYETHYL DIMETHYL BENZYL AMMONIUM CHLORIDE. DIISOBUTYLPHENOXYETHOXYETHYL DIMETHYL BENZYL AMMONIUM CHLORIDE WAS ADDED TO THE CAVI-WIPES FORMULATION FOR THE FIRST TIME IN 2012. THIS CHANGE IS BELIEVED TO BE A LIKELY CONTRIBUTOR TO THE CUSTOMER REPORTED INCREASE IN SEAR BREAKAGE. THE ROOT CAUSE OF THE REPORTED SEAR DAMAGE IS BELIEVED TO BE DUE TO ONE OR MORE FACTORS: PLASTIC EMBRITTLEMENT CAUSED BY CLEANING OF THE DEVICE WITH CHEMICALS THAT ARE NOT RECOMMENDED IN COMBINATION WITH PHYSICAL STRESSORS LED TO THE OBSERVED SEAR DAMAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BROKEN SEAR ON THE DOOR LATCH ASSEMBLY OF THE PUMP MODULE. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488128 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ALARIS PC UNIT: SN UNK