BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GP SERIES INFUSION SET, 1 SS Y

    MDR report key: 10909410 · Received November 26, 2020

    Report

    Report Number
    9616066-2020-20457
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    October 24, 2020
    Report Date
    December 17, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 11/20/2020. H.6. INVESTIGATION: ONE 60693E SAMPLE FROM LOT 1016422 WAS RECEIVED FOR INVESTIGATION OF WHICH THERE ARE TWO CHILD COMPLAINTS ASSOCIATED; REGARDING LEAKAGE FROM AN OPEN AIR VENT AND REGARDING A LEAKAGE FROM THE TUBING BELOW THE FLOW STOP COMPONENT. THE SAMPLE WAS RECEIVED WITH RESIDUAL FLUID PRESENT IN THE LINE. NO LEAKAGES WERE IDENTIFIED DURING EXAMINATION OF THE SAMPLE AND THEREFORE IT IS NOT POSSIBLE TO LINK THE SAMPLE TO ONE ISSUE OR THE OTHER. THE CUSTOMER DID PROVIDE A VIDEO WITH THE INITIAL FEEDBACK WHICH CONFIRMED THEIR REPORT OF LEAKAGE FROM THE AIR VENT. ANALYSIS OF THE VIDEO NOTED THAT THE AIR VENT CAP WAS OPENED AND THAT THE FLUID CONTAINER IN USE WAS AN IV BAG. IT WAS NOT POSSIBLE TO CONCLUSIVELY IDENTIFY A ROOT CAUSE FOR THIS ISSUE; HOWEVER SIMILAR LEAKAGE CAN BE REPLICATED WITH AN INCORRECT PRIMING TECHNIQUE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1016422 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GP SERIES INFUSION SET, 1 SS Y EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE LONG AND SHORT INFUSION THERAPY, THEY REALIZED THAT AIR VENT (WHICH IS A PART OF SET) IS LEAKING OUT LIQUID DROP BY DROP. THEY'VE FACED THREE TIMES REGARDLESS OF SLOW OR FAST INFUSION RATE. WHEN DETECTED, CAP OF AIR VENT WAS OPEN. NORMALLY, SET SHOULD NOT HAVE BEEN LEAKING OUT DRUG DESPITE OF CAP IS OPEN. ANOTHER COMPLAINT IS THAT SILICONE SIDE WAS BURST THEREFORE MEDICINE WAS LEAKING OUT FROM PUMP DURING INFUSION. PATIENT AND NURSES EXPOSED CHEMOTHERAPEUTIC AGENT DIRECTLY- THE DRUG DOSE WHICH SHOULD BE GIVEN WASN¿T ADMINISTRATED CORRECTLY- LESS DOSAGE THAN PLANNED- LOSS OF SETS. IT HAS BEEN FACED BOTH STANDARD AND LIGHT PROTECTION SETS OF ALARIS GP.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: AN INVALID LOT # OF 1016422 WAS PROVIDED BY THE INITIAL REPORTER. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GP SERIES INFUSION SET, 1 SS Y EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE LONG AND SHORT INFUSION THERAPY, THEY REALIZED THAT AIR VENT (WHICH IS A PART OF SET) IS LEAKING OUT LIQUID DROP BY DROP. THEY'VE FACED THREE TIMES REGARDLESS OF SLOW OR FAST INFUSION RATE. WHEN DETECTED, CAP OF AIR VENT WAS OPEN. NORMALLY, SET SHOULD NOT HAVE BEEN LEAKING OUT DRUG DESPITE OF CAP IS OPEN. ANOTHER COMPLAINT IS THAT SILICONE SIDE WAS BURST THEREFORE MEDICINE WAS LEAKING OUT FROM PUMP DURING INFUSION. PATIENT AND NURSES EXPOSED CHEMOTHERAPEUTIC AGENT DIRECTLY- THE DRUG DOSE WHICH SHOULD BE GIVEN WASN'T ADMINISTRATED CORRECTLY- LESS DOSAGE THAN PLANNED- LOSS OF SETS. IT HAS BEEN FACED BOTH STANDARD AND LIGHT PROTECTION SETS OF ALARIS GP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375098 GP SERIES INFUSION SET, 1 SS Y INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other