BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR

    MDR report key: 7346768 · Received March 16, 2018

    Report

    Report Number
    8041145-2018-00014
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    February 12, 2018
    Report Date
    April 9, 2018
    Manufacturer
    NIPRO (THAILAND) CORP., LTD.
    Product Code
    FJK
    PMA / PMN Number
    K072024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INVESTIGATION REPORT ATTACHED ON RETURNED, ACTUAL USED DEVICE. - ATTACHMENT: [INITIAL INVESTIGATION REPORT QC180301-301.PDF, FINAL INVESTIGATION REPORT (QC180301-301).PDF].

    Description of Event or Problem · 0

    AT APPROXIMATELY 1:25PM, 30 MINUTES INTO DIALYSIS TREATMENT, THE NURSE WAS RESPONDING TO A "VENOUS MINIMUM ALARM" ON THE SURDIAL-X DIALYSIS MACHINE. ACCORDING TO THE MACHINE HISTORY IT WAS ALARMING FOR A MINUTE AND A HALD, SHE THE NURSE NOTICED THE PATIENT WAS UNRESPONSIVE. NURSE CALLED EMERGENCY ASSISTANE AND NOTICED THAT THE PATIENT WAS COVERED IN BLOOD. IT WAS THEN NOTICED THAT THE VENOUS BLOOD LINE HAD BECOME DISCONNECTED FROM THE VENOUS LIMB OF THE CENTRAL VENOUS CATHETER. BLOOD WAS RUNNING OUT OF THE LINES AND THE VENOUS LIMB OF THE CATHETER. THE NURSE SAID THAT THERE WAS BLOOD FROM THE PATIENT'S HEAD ALL THE WAY DOWN TO HER FEET. THE PATIENT WAS EMERGENTLY BAGGED AND RESUSCITATED QUICKLY, BUT DUE TO THE AMOUNT OF AIR IN THE LINES, THE STAFF WAS UNABLE TO RETURN THE PATIENT'S BLOOD FROM THE EXTRACORPOREAL SYSTEM. THE PATIENT RECEIVED 3 UNITS OF BLOOD TRANSFUSION OVERNIGHT DUE TO HER HEMOGLOBIN BEING SO LOW (54) PORT INCIDENT. PATIENT HAS MADE A FULL RECOVERY SINCE THE INCIDENT. PATIENT VITALS PRE-TREATMENT: WEIGHT 81 KG, BP 163/117, PULSE 93, TEMP 37.4, BLOOD SUGAR 8.7 AND HGB 72.

    Description of Event or Problem · 1

    AT APPROXIMATELY 1:25PM, 30 MINUTES INTO DIALYSIS TREATMENT, THE NURSE WAS RESPONDING TO A "VENOUS MINIMUM ALARM" ON THE SURDIAL-X DIALYSIS MACHINE. ACCORDING TO THE MACHINE HISTORY IT WAS ALARMING FOR A MINUTE AND A HALD, SHE THE NURSE NOTICED THE PATIENT WAS UNRESPONSIVE. NURSE CALLED EMERGENCY ASSISTANCE AND NOTICED THAT THE PATIENT WAS COVERED IN BLOOD. IT WAS THEN NOTICED THAT THE VENOUS BLOOD LINE HAD BECOME DISCONNECTED FROM THE VENOUS LIMB OF THE CENTRAL VENOUS CATHETER. BLOOD WAS RUNNING OUT OF THE LINES AND THE VENOUS LIMB OF THE CATHETER. THE NURSE SAID THAT THERE WAS BLOOD FROM THE PATIENT'S HEAD ALL THE WAY DOWN TO HER FEET. THE PATIENT WAS EMERGENTLY BAGGED AND RESUSCITATED QUICKLY, BUT DUE TO THE AMOUNT OF AIR IN THE LINES, THE STAFF WAS UNABLE TO RETURN THE PATIENT'S BLOOD FROM THE EXTRACORPOREAL SYSTEM. THE PATIENT RECEIVED 3 UNITS OF BLOOD TRANSFUSION OVERNIGHT DUE TO HER HEMOGLOBIN BEING SO LOW (54) PORT INCIDENT. PATIENT HAS MADE A FULL RECOVERY SINCE THE INCIDENT. PATIENT VITALS PRE-TREATMENT: WEIGHT (B)(6) KG, BP 163/117, PULSE 93, TEMP 37.4, BLOOD SUGAR 8.7 AND HGB 72.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189134 NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR BLOODLINES FJK NIPRO (THAILAND) CORP., LTD. A372/V858R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R