BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAC PRN ASSEMBLY

    MDR report key: 15902257 · Received December 2, 2022

    Report

    Report Number
    9616066-2022-01839
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 3, 2022
    Report Date
    February 16, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED BY THE CUSTOMER THAT THE COMPONENT HAD A CRACK ON IT. AND PICTURES WERE PROVIDED. IT WAS NOT POSSIBLE A VISUAL INSPECTION SINCE SAMPLE WAS NOT PROVIDED, HOWEVER THROUGH THE PICTURES IT WAS POSSIBLE IDENTIFY THE DAMAGE IN THE NAC TOP. TO IDENTIFY THE POTENTIAL ROOT CAUSE FOR THE FAILURE MODE REPORTED IN CONJUNCTION WITH THE CMRB A GEMBA WALK WAS CARRIED OUT IN MOLDING AND AUTOMATION AREA AND THE RESULTS WERE CAPTURED INTO THE FOLLOW CAUSE-AND-EFFECT DIAGRAM. STERILIZATION PROCESS: SINCE THE MODEL REPORTED IS SELL AS BULK NO STERILE (OEM), THE STERILIZATION PROCESS WAS DISREGARDED, SINCE IS NOT NEED IT PER MODEL REQUIREMENTS. EXCESS DYE IN THE RESIN: THIS POSSIBLE CAUSE WAS DISREGARDED SINCE IT WAS FOUND THAT THE RESIN USED TO MOLD THE TOP OF THE 9100-335 MODEL DON¿T NEED DYE SINCE THE RESIN ALREADY HAS PIGMENTATION DESCRIBED IN THE DRAWING TC10008260 DIR 20000020301. WELDING AND CHARGING STATION: THE PROCESS WAS REVIEWED, AND THE CRACK DEFECT WAS NOT KNOWN IN THE PRODUCTION FLOOR SPECIFICALLY FOR THE COMPONENT TC10008260 (NAC TOP) . IN FACT TECHNICIAN MENTION THAT WHEN THE SUBASSEMBLY 620-00056(NAC PRN ASSEMBLY) IS DAMAGED IN THE MACHINE, THE DAMAGE IS PRESENTED IN THE 3100-045(NAC PRN BOTTOM). ON THE OTHER HAND THE PROCESS WAS CHALLENGED PLACING SOME MANIPULATED TOPS IN THE NAC Y 4 MACHINE, IT HAS A HEIGHT SENSOR BEFORE THE WELDER STATION, SINCE THE CRACKS MODIFIES THE DIMENSIONS THE SAMPLES WERE MOVED TO THE SCRAP ONCE THEY WERE DETECTED. THEREFORE, MACHINE WAS NOT CONSIDERED A POTENTIAL ROOT CAUSE. INJECTION MOLD: THE INJECTION MOLD FOR THE NAC TOP TC10008260 WAS REVIEWED, AND NOT ANOMALIES WERE FOUND IN THE FUNCTION OF THE MOLDING TOOL. SINCE THE CRACK WAS FOUND IN THE INJECTION POINT, A POTENTIAL CAUSE COULD BE RELATED TO THE TEMPERATURE IN THAT SPECIFIC POINT. THEREFORE, INJECTION MOLD WAS NOT CONSIDERED A POTENTIAL ROOT CAUSE. DISREGARDED SINCE THE ENVIRONMENT IS NOT RELATED TO THIS FAILURE MODE. DISREGARDED SINCE PERSONNEL IS NOT RELATED TO THIS FAILURE MODE DUE THE PRODUCTION IS AUTOMATED. MEASUREMENT METHOD IS CARRIED OUT ACCORDING TO DRAWING REQUIREMENT FOR FIRST ARTICLE WHEN APPLIES, IN THIS CASE, THE TOP IS TESTED UNDER ELONGATION TEST TO DEFINE THE HARDNESS OF THE MATERIAL AND DETECT ANY POSSIBLE ISSUE AS THE CRACKS. DHRS FROM LOTS OF COMPONENTS USED TO BUILD THE LOT REPORTED UNDER THIS PR SHOWN THAT PIECES OF ALL THE PIECES PASS THE ELONGATION TEST REQUIRED BY DRAWING. THEREFORE, MEASUREMENT WAS NOT CONSIDERED A POTENTIAL ROOT CAUSE. AFTER THE PROCESS REVIEW AND CHALLENGED MANIPULATING SAMPLES OF TOPS, THE FAILURE MODE COULD NOT BE REPLICATED, THEREFORE, THE ROOT CAUSE WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: IT WAS REPORTED BY THE CUSTOMER THAT THE COMPONENT HAD A CRACK ON IT. AND PICTURES WERE PROVIDED. THROUGH THE PICTURES IT WAS POSSIBLE IDENTIFY THE DAMAGE IN THE NAC TOP. TO IDENTIFY THE POTENTIAL ROOT CAUSE FOR THE FAILURE MODE REPORTED IN CONJUNCTION WITH THE CMRB A GEMBA WALK WAS CARRIED OUT IN MOLDING AND AUTOMATION AREA AND THE RESULTS WERE CAPTURED INTO THE FOLLOW CAUSE-AND-EFFECT DIAGRAM. DHRS FROM LOTS OF COMPONENTS USED TO BUILD THE LOT REPORTED SHOWN THAT PIECES OF ALL THE PIECES PASS THE ELONGATION TEST REQUIRED BY DRAWING. ROOT CAUSE DEFINITION: AFTER THE PROCESS REVIEW AND CHALLENGED MANIPULATING SAMPLES OF TOPS, THE FAILURE MODE COULD NOT BE REPLICATED, THEREFORE, THE ROOT CAUSE WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING NAC PRN ASSEMBLY THE DEVICE WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT IS RELATED TO CRACK FOUND ON COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING NAC PRN ASSEMBLY THE DEVICE WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT IS RELATED TO CRACK FOUND ON COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526252 NAC PRN ASSEMBLY INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 21044024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown