BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    MDR report key: 1671239 · Received April 30, 2010

    Report

    Report Number
    1423500-2010-00654
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). SAMPLE NOT AVAILABLE. THIS PERITONITIS CASE IS THE SAME PERITONITIS REPORTED IN REPORT NUMBER 1423500-2010-00652. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE TRANSFER SET.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE WITH SETUP ON THE HOMECHOICE (HC) MACHINE AT PRESS GO TO START. THE CAREGIVER (CG) STATED THAT THEY HAD SETUP THE HC MACHINE FOR THERAPY AND THEN THE HP NEEDED TO GO TO THE HOSPITAL. THE CG HAD TURNED OFF THE HC MACHINE AND THEN THE HC MACHINE WAS BACK AT "PRESS GO TO START". THE HOME PATIENT (HP) WANTED TO KNOW WHAT TO DO. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) BEGAN TO INSTRUCT CG ON HOW TO CONTINUE WITH SETUP WHEN THE CALL WAS LOST. THE HC DEVICE WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE NURSE ON 4/5/2010 TO OBTAIN ADDITIONAL INFORMATION ABOUT GOING TO HOSPITAL, IT WAS REVEALED THAT THE HP WAS ADMITTED TO THE HOSPITAL DUE TO PERIPHERAL VASCULAR DISEASE (PVD) AND IS STILL IN THE HOSPITAL. AS A RESULT OF THE PVD, THE NM STATED THAT HP'S LEG WAS AMPUTATED. THE NM FURTHER REVEALED THAT WHILE AT THE HOSPITAL, HP ALSO CONTRACTED HOSPITAL-ACQUIRED PERITONITIS. THE NM STATED THAT SHE DID NOT HAVE ANY FURTHER INFORMATION. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. PRODUCT SURVEILLANCE RECEIVED FOLLOW-UP INFORMATION VIA EMAIL FROM GLOBAL PHARMACOVIGILANCE FOLLOWING CONTACT WITH THE PD NURSE ON 4/12/2010. PER THE NURSE, THE PATIENT'S PERIPHERAL VASCULAR DISEASE (PVD) WAS A PRE-EXISTING CONDITION. ON (B) (6) 2010, WHEN THE PATIENT STATED THEY WERE GOING TO THE HOSPITAL IT WAS FOR A SCHEDULED LEG AMPUTATION (LEG AMPUTATED UNKNOWN). THE NURSE STATED THAT THE PATIENT'S PVD WAS VERY SEVERE WHEN HE CAME TO PD THERAPY AND IN FACT THE PHYSICIAN WANTED THE PATIENT TO HAVE THE AMPUTATION PRIOR TO STARTING PD THERAPY, BUT THE PATIENT DELAYED AND WAITED. THE NURSE STATED THE PVD DID NOT WORSEN SINCE STARTING PD THERAPY. PER THE NURSE, ON (B) (6) 2010, WHEN THE PATIENT WAS HOSPITALIZED HE WAS SWITCHED FROM DIANEAL PD4 AMBUFLEX THERAPY TO DIANEAL PD4 ULTRABAG BECAUSE THE HOSPITAL DOES NOT USE THE HOMECHOICE MACHINE. IN (B) (6) 2010, WHILE HOSPITALIZED THE PATIENT WAS DIAGNOSED WITH PERITONITIS. NURSE DOES NOT KNOW IF A PERITONEAL EFFLUENT ANALYSIS OR GRAM STAIN WERE PERFORMED. ALL THE NURSE KNOWS IS THAT THE CULTURE WAS NO GROWTH AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. IN (B) (6) 2010, WHILE STILL IN THE HOSPITAL, THE PATIENT HAD DEVELOPED ANOTHER PERITONITIS. AGAIN, THE NURSE DOES NOT KNOW IF A PERITONEAL EFFLUENT ANALYSIS OR GRAM STAIN WERE PERFORMED. ALL THE NURSE KNOWS IS THAT THE CULTURE GREW OUT SOME BACTERIA. AFTER THIS CULTURE CAME BACK, THE PATIENT'S PD CATHETER WAS PULLED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. PER THE NURSE, THE PATIENT'S PD CATHETER WAS PULLED BECAUSE OF THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT IS STILL IN THE HOSPITAL. THE NURSE DID NOT KNOW IF THE PATIENT HAD AN EXIT SITE INFECTION WITH THE TWO PERITONITIS EPISODES. THE NURSE DOES NOT KNOW THE OUTCOME FOR THE EVENTS OF THE TWO EPISODES OF PERITONITIS. THE NURSE DOES NOT KNOW WHAT CAUSED THE PATIENT TO DEVELOP THE TWO EPISODES OF PERITONITIS WHILE IN THE HOSPITAL. THE NURSE DID NOT THINK THAT THE TWO EPISODES OF PERITONITIS WERE RELATED TO DIANEAL THERAPIES, BUT SHE DID NOT KNOW FOR SURE. PER THE NURSE, SHE HAS NO FURTHER INFORMATION AS THESE EVENTS OCCURRED IN THE HOSPITAL AND SHE DOES NOT HAVE ACCESS TO THE FILES IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR LOCAL (PD4) ULTRABAG