BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUINTON

    MDR report key: 67832 · Received December 31, 1996

    Report

    Report Number
    67832
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    November 6, 1996
    Report Date
    November 11, 1996
    Manufacturer
    QUINTON INSTRUMENTS
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT 3HRS 40 MINS INTO ROUTINE HEMODIALYSIS TRETMENT AND COMPLAINED OF BACK PAIN. VSS SAFETY CHECKS DONE, NO VISIBLE KINKS IN LINE NOTED. AFTER TREATMENT PT RETURNED TO UNIT WITH COMPLAINTS OF BACK PAIN AND HEMATURIA. MD NOTIFIED AND PT SENT TO THE ER FOR EVALUATION. ARTERIAL LINE WAS ON #2 REUSE. DIALYZER ON 19TH REUSE. CATHETER ON RIGHT SIDE IN PLACE SINCE 7/27/96. NO RESIDUAL STERILANT OR BLEACH PRE-TREATMENT. NO OTHER PTS INVOLVED. MACHINE PULLED, ALL SAFETY CHECKS AND CALIBRATIONS WERE FUNCTIONING PROPERLY. THE VENOUS PRESSURE DID FLUCTUATE BETWEEN 240-120 DURING COURSE OF TREATMENT. (PT STILL HOSPITALIZED AS OF 11/8).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUINTON Implant HEMODIALYSIS CATHETER LFJ QUINTON INSTRUMENTS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization 3) FRESENIUS 2008E MACHINE| 2) NMC VENOUS BLOOD LINE & ARTERIAL BLOODLINE| 1) CLINRANS T-175 DIALYZER