BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 2853395 · Received November 30, 2012

    Report

    Report Number
    1416980-2012-06266
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF HERNIA AND CONSTIPATION. THE REPORTED ISSUE WITH REGARDS TO THE DEVICE WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(4) 2012 REGARDING A LOW DRAIN VOLUME ALARM. THE HP STATED THEY HAVE BEEN WORKING ON THE DRAINING ISSUES WITH THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PD RN). THEY STATED THEY FOUND OUT THEY CURRENTLY HAVE A HERNIA WHICH THE PD RN BELIEVE IS OBSTRUCTING THEIR CATHETER. THEY STATED THEY ALSO HAVE BEEN CONSTIPATED SO THEY THINK BOTH THESE ISSUES ARE CAUSING THESE ALARMS. THEY STATED THEY HAVE BEEN ABLE TO FINISH THEIR THERAPIES USING MANUAL SUPPLIES. THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) WAS CONTACTED ON (B)(6) 2012 IN ORDER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE HOME PATIENT'S (HP) REPORT OF HERNIA. THE PDRN STATED THAT THIS WAS A NEW HERNIA DIAGNOSIS SINCE THE START OF (B)(6). THE HP HAS SEEN THE SURGEON AND IS PLANNING ON HAVING THE HERNIA REPAIRED DUE TO THE PD CATHETER BEING WRAPPED AROUND THE HERNIA. THE LOCATION OF THE HERNIA WAS UNKNOWN. THE PDRN STATED THAT SHE DID NOT KNOW IF THE HERNIA WAS RELATED TO PD THERAPY. NO FURTHER INFORMATION WAS GIVEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other DIANEAL LOW CAL 2.5% DEX 6L/6L| LOW CA 1.5% 2L/2L UB DIANEAL| DIANEAL LOW CA 4.25% 6L/6L| DIANEAL LOW CA 1.5% DEX 6L/6L| LOW CA 2.5% 2L/2L UB DIANEAL