BEUDAMED
    FDA Adverse Event Other Summary report: N

    NXSTAGE DIALYSATE BAG

    MDR report key: 19918024 · Received August 5, 2024

    Report

    Report Number
    MW5158014
    Event Type
    Other
    Date Received
    August 5, 2024
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KPO
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I REPORTED A SIMILAR ISSUE LAST FRIDAY BUT DID NOT GET A CONFIRMATION OF RECEIPT SO WILL INCLUDE ALL CONTENT IN THIS SUBMISSION. WE HAVE SEEN A TREND OF RFP 404 & 400 NXTSTAGE DIALYSATE BAGS "EXPLODING" WHEN THE NURSES GO TO BREAK THE SEAL BETWEEN THE TWO COMPARTMENTS. THE SPECIFIC LOTS THAT HAVE BEEN AN ISSUE ARE Q2401304 AND Q2311266. ONE NURSE NEEDED TO BE SEEN IN THE EMERGENCY DEPARTMENT DUE TO EYE EXPOSURE. RFP- 404 6-7 EVENTS FOR LOT Q2311266: WHEN OUTER BAG WAS OPENED, ELECTROLYTE SIDE OF BAG NOTED TO HAVE A SMALL HOLE, DISCARDED A NEW BAG OBTAINED 8 EVENTS FOR LOT Q2401304: BAGS "RUPTURING AT THE SEEMS" OR "POPPING" WHEN INNER SEAL IS BROKEN FOR MIXING. ISMP, 5200 BUTLER PIKE, PLYMOUTH MEETING, PA 19462 I PHONE: 215-947-7797 I EMAIL: [email protected]. SUBMISSION ID: (B)(4). REFERENCE REPORTS MW5158005, MW5158006, MW5158007, MW5158008, MW5158071, MW5158010, MW5158011, MW5158012, MW5158013, MW5158015, MW5158016, MW5158017, MW5158018, MW5158019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592797 NXSTAGE DIALYSATE BAG DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO NXSTAGE MEDICAL, INC. RFP-400 Q2311266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown