BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4221979 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38605
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (PD) THERAPY MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE CAUSE OF PERITONITIS WAS UNKNOWN FURTHER DESCRIBED AS POOR SURROUNDING ENVIRONMENT WITH NO FURTHER DETAILS PROVIDED. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON THE SAME DAY AS ONSET, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH CEFAZOLIN AND CEFTAZIDIME (250 MILLIGRAMS, 4 TIMES A DAY, ROUTE NOT REPORTED). TWO DAYS LATER, THE PATIENT'S TREATMENT WITH CEFAZOLIN AND CEFTAZIDIM WAS DISCONTINUED. THE FOLLOWING DAY, THE PATIENT BEGAN TREATMENT FOR PERITONITIS WITH ENTINAM (200 MILLIGRAMS, 4 TIMES A DAY, ROUTE NOT REPORTED) AND AMIKACIN (25 MILLIGRAMS, 4 TIMES A DAY, ROUTE NOT REPORTED) FOR PERITONITIS. THIRTEEN DAYS LATER, TREATMENT WITH ENTINAM AND AMIKACIN WAS DISCONTINUED. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, THE PERITONITIS WAS RESOLVED AND THE PATIENT WAS RECOVERED. AT THE TIME OF THIS REPORT, DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701578 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 1.5% DIANEAL PD4, 2.5% DIANEAL PD4,| TRANSFER SET, TITANIUM ADAPTER