BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2073153 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05216
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. IT IS UNKNOWN IF THIS INCIDENT INVOLVED A HOMECHOICE OR HOMECHOICE PRO DEVICE; HOWEVER, THE 510K NUMBER IS BEING PROVIDED AS IT IS THE SAME FOR BOTH OF THESE DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED AND A CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA.

    Description of Event or Problem · 1

    BAXTER CLINICAL EDUCATOR (CE) CALLED CORPORATE PRODUCT SURVEILLANCE (B)(6) 2011 TO RELAY REPORT RECEIVED FROM THE HOME PATIENT'S PERITONEAL DIALYSIS (PD) NURSE WHILE VISITING THE DIALYSIS UNIT (B)(6) 2011. CE STATED THAT THE PD NURSE RECEIVED A CALL (B)(6) 2011 FROM THE HP WHO WAS IN THE HOSPITAL BEING TREATED FOR UNKNOWN REASON(S). PER CE, THE HP CALLED THE PD NURSE SAYING HE WAS SHORT OF BREATH WHILE STILL CONNECTED TO THE HOSPITAL'S HOMECHOICE MACHINE, SERIAL NUMBER UNKNOWN. THE CE RELAYED THAT PD NURSE ASSISTED THE HP TO "HIT MANUAL DRAIN" AND THE HP DRAINED 6000CC'S OF FLUID AT AN UNKNOWN TIME THE MORNING OF (B)(6) 2011. IT IS UNKNOWN AT THIS TIME WHICH PD SOLUTION(S) WAS/WERE INVOLVED IN THE EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP'S PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF THE HIGH DRAIN AND HOSPITAL. THE PDN VERIFIED THE HP'S LARGEST PRESCRIBED FILL VOLUME (LPFV) AT HOME IS 2900ML BUT WAS FILLED WITH 2000ML WHILE IN THE HOSPITAL. THE PDN STATED THE HP WAS HAVING A LOW DRAIN VOLUME ALARM AND THE HOSPITAL RN CALLED BAXTER FOR ASSISTANCE WITH BYPASSING THE ALARM. THE HP WAS IN DWELL 4 WHEN HE STARTED HAVING SYMPTOMS OF SHORTNESS OF BREATH AND PAIN. THE HOSPITAL RN CALLED THE PDN WHO ASSISTED WITH THE MANUAL DRAIN. THE HP DRAINED 6000ML. THE PDN STATED THE HP HAD HERNIA SURGERY IN (B)(6) 2010 THAT WAS UNRELATED TO THERAPY AND WAS CURRENTLY IN THE HOSPITAL FOR SPINAL SURGERY. THE PDN DID NOT HAVE CYCLER INFORMATION AS THIS OCCURRED IN THE HOSPITAL ON THE HOSPITALS CYCLER. A SWAP WAS NOT REQUESTED. THE PDN STATED THE HP HAS NOT REPORTED ANY OTHER SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. ALL INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR