BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1932570 · Received December 18, 2010

    Report

    Report Number
    1423500-2010-07037
    Event Type
    Injury
    Date Received
    December 18, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE ONSET OF THIS EVENT IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION, THIS MALFUNCTION AND HERNIA INJURY HAS BEEN DETERMINED TO BE A NONREPORTABLE MALFUNCTION AND NONREPORTABLE INJURY. THE PATIENT WAS USING ULTRABAGS AND NOT RECEIVING DIALYSIS WITH THE CASSETTE OR HOME CHOICE AT THE TIME OF THIS OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A QUESTION ABOUT PRIMING THE PATIENT LINE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING PRIME, PATIENT NOT CONNECTED. THE HOME PATIENT (HP) REPORTED HAVING PROBLEMS REPRIMING THE PATIENT LINE. THE HP USES ONE PATIENT LINE EXTENSION. THE HP STATED THAT HE CONNECTED AND PERFORMED THERAPY WITH AIR IN THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) SUGGESTED THAT THE HP SHOULD CALL BAXTER WHEN HE IS HAVING A PROBLEM PRIMING THE PATIENT LINE. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, GLOBAL PRODUCT SURVEILLANCE RECEIVED THIS ADDITIONAL INFORMATION ON A CALL TO THE PATIENT'S PDRN. THE PATIENT INITIATED PERITONEAL DIALYSIS (PD) TRAINING ON (B)(6) 2010, MODALITY CONTINUOUS AMBULATORY PERITONEAL DIALYSIS(CAPD). SCROTAL EDEMA WAS NOTED A FEW DAYS AFTER BEGINNING CAPD. THE PDRN STATED THAT THE PATIENT CONSULTED WITH A SURGEON. SINCE THE PATIENT IS A RATHER LARGE, ELDERLY MAN, HE MAY HAVE HAD A WEAKENED PERITONEAL WALL PRIOR TO CAPD, AND CARRYING A LARGE AMOUNT OF FLUID DURING THE DAY MAY HAVE CAUSED THE EVENT. ON (B)(6) 2010, THE PATIENT SWITCHED TO AUTOMATED PERITONEAL DIALYSIS (APD) WITH THE HC AT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R