BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1698486 · Received May 21, 2010

    Report

    Report Number
    8030638-2010-00004
    Event Type
    Injury
    Date Received
    May 21, 2010
    Date of Event
    April 24, 2010
    Report Date
    April 27, 2010
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION. RETAINED BLOOD TUBING SAMPLES FROM LOT NUMBER REPORTED 01R158216 WERE VISUALLY INSPECTED, FUNCTIONAL AND DIMENSIONAL TESTING PERFORMED WITH NO FAILURES DETECTED.

    Description of Event or Problem · 1

    DURING THE HEMODIALYSIS TREATMENT ON (B)(6) 2010, THE PT WAS NOT ANTICOAGULATED, THERE WAS DIFFICULTY WITH CANNULATION SO, THE NURSE OPTED TO SWITCH ACCESS SITES. THE BLOOD HAD ALREADY FILLED THE CIRCUIT AND IT WAS STAGNANT FOR A FEW MINUTES WHILE THE NURSE MOVED SITES. IMMEDIATELY UPON INITIATING TREATMENT, THE PT'S BLOOD PRESSURE INCREASED AND THE ARTERIAL AND VENOUS PRESSURE READINGS WERE SIGNIFICANTLY ABNORMAL ALONG WITH AN ELEVATED TRANSMEMBRANE PRESSURE. TREATMENT CONTINUED ON ANOTHER MACHINE AND THE PT WAS DISCHARGED HOME. NO KINKS IN ANY OF THE LINES WERE FOUND. THE NURSE ALSO DID NOT OBSERVE THE LINES BOUNCING AND DID NOT HEAR ANY UNUSUAL NOISES COMING FROM THE BLOODLINES. NINE HOURS AFTER COMPLETING HER HEMODIALYSIS TREATMENT, THE PT WAS ADMITTED TO THE HOSP, WITH DIAGNOSIS OF HEMOLYSIS AND ACUTE PANCREATITIS. THE LAB WORK REVEALED A DECREASE IN HEMOGLOBIN AND HAPTOGLOBIN, AND ELEVATED AMYLASE, LIPASE, AST AND ALT. NO BLOOD SMEAR WAS OBTAINED. THE CAUSE OF THE HEMOLYSIS IS UNK. WHILE HOSPITALIZED THE PT'S CONDITION QUICKLY IMPROVED. ON (B)(6) 2010, SHE RESUMED HER REGULAR OUTPATIENT HEMODIALYSIS TREATMENT SCHEDULE. NO PROBLEMS WERE REPORTED. THE BLOOD TUBING SET WAS DISCARDED AND IS NOT AVAILABLE FOR INSPECTION. TWO HOSP BIOMED TECHNICIAN AND A GAMBRO SERVICE TECH INSPECTED THE PHOENIX MACHINE. NO PROBLEMS WERE FOUND. THE GAMBRO SERVICE TECHNICIAN AUTHORIZED THE RETURN OF THE MACHINE TO CLINICAL USE. IT HAS BEEN RETURNED TO CLINICAL USE, WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO CARTRIDGE BLOOD SET BLOOD TUBING SET FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. NA 01R158216

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R BAXTER CT190G| BICART 1250, LOT UNK| PHOENIX MACHINE, (B)(4), SW 3.36| MEDISYSTEMS, 15 GA