BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET

    MDR report key: 5104412 · Received September 24, 2015

    Report

    Report Number
    8030665-2015-00445
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 22, 2015
    Report Date
    March 10, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POST MARKET SURVEILLANCE DEPARTMENT REVIEWED THE PATIENT'S MEDICAL RECORDS AND THE CLINICAL INVESTIGATION REVEALS THE FOLLOWING: BASED ON THE 13 PAGES OF MEDICAL RECORDS AND INFORMATION OBTAINED FROM VERBAL REPORTS: ACCORDING TO THE PATIENT, THE SOLUTION WAS TOO HOT AND BURNT THE INSIDE OF HIS STOMACH. THE PATIENT STATED THE SCREEN ON THE CYCLER READ, "PLEASE WAIT FRO SOLUTION TO COOL DOWN." THE PATIENT STATED HIS WIFE HELPED HIM PERFORM A STAT DRAIN. MEDICAL RECORDS DO NOT CONTAIN HOSPITAL RECORDS, HISTORY AND PHYSICAL, PROGRESS NOTES, LAB OR DIAGNOSTIC RESULTS, DISCHARGE SUMMARY OR DIAGNOSES FOR REVIEW. MEDICAL RECORDS DO NOT REVEAL THE PATIENT WAS DIAGNOSED WITH SEPTIC SHOCK. MEDICAL RECORDS DO NOT INDICATE PATIENT WAS BURNED DURING DIALYSIS. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT INDICATES THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S LIBERTY CYCLER AND THE PATIENT'S ALLEGED HOSPITALIZATION FOR SEPTIC SHOCK. ON 09/22/2015 PLANT EVALUATION: THE ACTUAL PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THE ACTUAL PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER OVER THE PAST THREE MONTHS. DEVICE HISTORY RECORD REVIEW WAS PERFORMED. NO NON-CONFORMANCE REPORTS OR OTHER ABNORMALITIES DURING THE ASSEMBLY OF RELATED LOTS WERE FOUND. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NON-CONFORMANCE'S DURING THE MANUFACTURING PROCESS. PRODUCT LABELING, MATERIAL AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) PATIENT CALLED TECHNICAL SUPPORT TO REPORT ON (B)(6) 2015 THE PD SOLUTION WAS TOO HOT AND BURNED THE INSIDE OF HIS STOMACH. HE ADDED THAT HE HAS BEEN COMPLETING TREATMENTS MANUALLY SINCE THIS EVENT. HE STATED THAT THE CYCLER DID DISPLAY THE WARNING MESSAGE "PLEASE WAIT FOR SOLUTION TO COOL DOWN." UPON FOLLOW UP WITH THE PATIENT'S PDRN, SHE STATED THAT SHE WAS NOT AWARE OF THE PATIENT'S BURN FORM THE SOLUTION BEING TOO HOT. HOWEVER, THE PATIENT IS CURRENTLY IN ICU DUE TO SEPTIC SHOCK AND SHE DOES NOT KNOW IF THIS IS RELATED TO AN INFECTION AS A RESULT OF THE BURN. THE PATIENT'S MEDICAL RECORDS WERE REQUESTED.

    Description of Event or Problem · 1

    A CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) PATIENT CALLED TECHNICAL SUPPORT TO REPORT ON (B)(6) 2015 THE PD SOLUTION WAS TOO HOT AND BURNED THE INSIDE OF HIS STOMACH. HE ADDED THAT HE HAS BEEN COMPLETING TREATMENTS MANUALLY SINCE THIS EVENT. HE STATED THAT THE CYCLER DID DISPLAY THE WARNING MESSAGE "PLEASE WAIT FOR SOLUTION TO COOL DOWN." UPON FOLLOW UP WITH THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), SHE STATED THAT SHE WAS NOT AWARE OF THE PATIENT'S BURN FROM THE SOLUTION BEING TOO HOT. HOWEVER, THE PATIENT IS CURRENTLY IN ICU DUE TO SEPTIC SHOCK AND SHE DOES NOT KNOW IF THIS IS RELATED TO AN INFECTION AS A RESULT OF THE BURN. THE PATIENT'S MEDICAL RECORDS WERE REQUESTED. SUBSEQUENT FOLLOW UP WITH THE PATIENTS PDRN CONFIRMED THAT THE PATIENTS ALLEGED "BURN" NEVER OCCURRED. PDRN STATES THAT THERE IS NO MENTION OF A BURN IN ANY MEDICAL RECORDS. ACCORDING TO THE PDRN THE "SEPTIC SHOCK" INFECTION" THAT RESULTED IN A HOSPITALIZATION WAS CONFIRMED TO BE PERITONITIS. THE NURSE BELIEVES THAT THE PATIENT MAY HAVE MEANT HE FELT A "BURNING SENSATION" LIKELY DUE TO THE INFECTION/PERITONITIS THAT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633347 LIBERTY CYCLER SET FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization