BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 3SS CV

    MDR report key: 11418361 · Received March 4, 2021

    Report

    Report Number
    9616066-2021-50356
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    January 3, 2021
    Report Date
    February 24, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THE AFFECTED PRODUCT TO BE A (B)(4), HOWEVER TWO (B)(4) SAMPLES WERE RECEIVED FOR INVESTIGATION WITH RESIDUAL FLUID PRESENT IN THE LINE; NO PACKAGING WAS RECEIVED WITH THE SAMPLES, HOWEVER THE CUSTOMER INDICATES THE AFFECTED LOT NUMBER TO BE 20087371. ONE OF THE SAMPLES WAS RECEIVED SPIKED INTO A 82113EH BURETTE SET, WHICH WAS SPIKED INTO A BAXTER 1000ML GLUCOSE IV BAG, THE SECOND SAMPLE WAS RECEIVED SPIKED INTO A FRESENIUS KABI 10ML NACL SEMI-RIGID CONTAINER. A VISUAL INSPECTION OF BOTH (B)(4) SAMPLES DID NOT IDENTIFY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. FUNCTIONAL TESTING WAS PERFORMED BY FLUSHING EACH SAMPLE WITH FLUID; NO ISSUES WERE IDENTIFIED DURING FLUSHING. DURING TESTING IT WAS NOTED THAT THE CUSTOMER'S EXPERIENCE COULD BE REPLICATED BY APPLYING A BOLUS INTO THE SET WHILE OCCLUDING THE MALE LUER. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20087371 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE, BALLOONING OF THE SILICONE SEGMENT IS NOT A MANUFACTURING DEFECT AND IS TYPICALLY CAUSED BY AN EXCESSIVELY HIGH INTERNAL PRESSURE. PREVIOUS INVESTIGATIONS HAVE IDENTIFIED THAT ADMINISTERING AN IV PUSH WITHOUT CLAMPING THE LINE BETWEEN THE INJECTION PORT AND THE PUMPING SEGMENT CAN CREATE AN INTERNAL PRESSURE HIGH ENOUGH TO CAUSE THIS EFFECT. A REVIEW OF THE DATABASE INDICATES THAT THERE HAVE BEEN A SMALL NUMBER OF SIMILAR COMPLAINTS, HOWEVER THEY HAVE NOT BEEN ATTRIBUTABLE TO A PRODUCT DEFECT OR MANUFACTURING ISSUE. INVESTIGATION CONCLUSION: TWO (B)(4) SAMPLES WERE RECEIVED FOR INVESTIGATION WITHOUT PACKAGING AND RESIDUAL FLUID WAS PRESENT IN BOTH TUBE LININGS. ONE SAMPLE, WAS RECEIVED CONNECTED TO AN ADDITIONAL BURETTE SET WHICH WAS CONNECTED TO A BAXTER 1000ML GLUCOSE IV BAG. THE OTHER (B)(4) SAMPLE WAS RECEIVED CONNECTED TO A FRESENIUS KABI 10ML NACL BOTTLE. A VISUAL INSPECTION REVEALED NO INDICATION OF DAMAGE. FUNCTIONAL INVESTIGATION WAS PERFORMED BY FLUSHING EACH SAMPLE WITH FLUID; NO BULGING OR DAMAGE WAS IDENTIFIED DURING FLUSHING. FURTHER TESTING WAS PERFORMED BY APPLYING PRESSURED FLUID TO THE PUMP SEGMENT SECTION; BULGE WAS IDENTIFIED AT THE UPPER PUMP SEGMENT IN EACH SAMPLES CONFIRMING THE CUSTOMERS REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 AS LVP 20D 3SS CV EXPERIENCED TUBING THAT BALLOONED/EXPANDED/BULGED, RUPTURED TUBING, FLOW ISSUES, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GIVING SET X2 FLUSHED WHILST STILL INSERTED INTO PUMP. IN BOTH OCCASIONS THE ROLLER CLAMP ON GIVING SET CLAMPED BETWEEN PATIENT AND PUMP. LINE FLUSHED HOWEVER CVL DIFFICULT TO FLUSH AND LINE RUPTURED AT TOP POINT OF SILICONE SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311568 AS LVP 20D 3SS CV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20087371

    Patients

    Seq Age Sex Outcome Treatment
    1