BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - HARDWARE

    MDR report key: 1724012 · Received June 15, 2010

    Report

    Report Number
    1423500-2010-01145
    Event Type
    Injury
    Date Received
    June 15, 2010
    Date of Event
    April 3, 2009
    Report Date
    May 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM (B)(6) HOSPITAL DOCUMENTATION INDICATES THE FOLLOWING: A PERITONEAL DIALYSIS CATHETER WAS PLACED FOR DIALYSIS ON (B)(6) 2006. ON (B)(6) 2008, A PELVIC SONOGRAM, ABDOMINAL SONOGRAM, AND CT OF THE UPPER ABDOMEN AND PELVIS WITH INTRAVENOUS CONTRAST MATERIAL NOTED A BENIGN SPLENIC CYST AND OVARIAN CYST. DIALYSIS CATHETER IN PLACE AND FUNCTIONING. ON (B)(6) 2008, THE ULTRASOUND WAS CLEAR. ON (B)(6) 2009, THE ATTENDING PHYSICIAN NOTE INDICATED: THE PATIENT COMPLAINED OF ABDOMINAL PAIN ONE WEEK PRIOR TO ADMISSION WITH SOME CLOUDY PERITONEAL FLUID. CULTURE AND SENSITIVITY WAS PERFORMED AND GREW CITROBACTER FRUENDI. THE PATIENT DID NOT RESPOND WELL TO OUTPATIENT TREATMENT AND WAS ADMITTED AND STARTED ON INTRAVENOUS ANTIBIOTICS (UNKNOWN). NO EVIDENCE OF TENDERNESS OR ERYTHEMA ASSOCIATED WITH THE CATHETER TRACT. DIAGNOSIS WAS PERITONEAL DIALYSIS PATIENT WITH APPARENT CITROBACTER PERITONITIS. ON (B)(6) 2009, A CT OF THE ABDOMEN AND PELVIS WITH CONTRAST WAS PERFORMED. NOTED THAT A BOWEL PERFORATION COULD NOT BE RULED OUT IN THE LEFT LOWER QUADRANT. ON (B)(6) 2010, A LAPAROTOMY, COLON RESECTION WITH REANASTOMOSIS, REMOVAL OF PERITONEAL DIALYSIS CATHETER AND INSERTION OF TEMPORARY DIALYSIS CATHETER WAS PERFORMED. ON EXAMINATION OF THE SIGMOID COLON, IN THE MID PORTION OF THE SIGMOID COLON, A 4-5 MM PERFORATION WAS FOUND. OTHER THAN GENERALIZED PERITONITIS, THERE WAS VERY LITTLE INDICATION OF INFLAMMATORY RESPONSE IN THE AREA AND IT WAS NOT FELT TO BE TYPICAL FOR DIVERTICULITIS WITH PERFORATION. A LIMITED COLON RESECTION WAS PERFORMED. MICROSCOPIC EXAMINATION INDICATED: SECTION REVEALED A DIVERTICULAR OUTPOUCHING OF MUCOSA INTO THE SUBJACENT FIBROFATTY TISSUE. ASSOCIATED CHRONIC INFLAMMATORY INFILTRATE AND PERICOLIC FIBROSIS WERE NOTED. ON (B)(6) 2010, THE TEMPORARY DIALYSIS CATHETER WAS REPLACED WITH A TUNNELED DIALYSIS CATHETER. THE PATIENT TOLERATED THE PROCEDURE WELL. AS OF (B)(6) 2009, THE PHYSICIAN NOTES OK TO PROCEED WITH PREPARATION FOR TRANSPLANT. ON (B)(6) 2009, THE NOTES INDICATE THE TRANSPLANT WAS DELAYED DUE TO ANTIBODIES. ON (B)(6) 2010, A LAPAROSCOPIC INSERTION OF A PERITONEAL DIALYSIS CATHETER WAS PERFORMED. DURING SURGERY, IT WAS NOTED THERE WERE FAIRLY EXTENSIVE FILMY ADHESIONS BUT NOTHING TO PREVENT USE OF THE PERITONEAL DIALYSIS CATHETER. ADHESIONS THAT WERE FELT TO POSSIBLY REPRESENT A PROBLEM POSTOP OR FOR PERITONEAL DIALYSIS WERE REMOVED. THE CATHETER WAS INSERTED AND THE INSERTING PORT WAS REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2009, THE PATIENT UNDERWENT LAPAROSCOPY, ENTEROLYSIS AND REPOSITIONING OF PERITONEAL DIALYSIS CATHETER. DURING SURGERY, IT WAS NOTED THAT FRESH ADHESIONS WERE NOTED IN THE RIGHT ABDOMEN PARTICULARLY IN THE RIGHT LOWER QUADRANT. THE INTRAPERITONEAL CATHETER WAS COMPLETELY ENCASED WITH ADHESIONS WHICH HAD CAUSED A COMPLETE OCCLUSION INTRAPERITONEALLY. CATHETER IRRIGATED, REPOSITIONED AND FELT TO BE FUNCTIONAL WITH GOOD INFLOW AND OUTFLOW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED THEREFORE, NO EVALUATION WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). ALTHOUGH PREDILATATION WAS PERFORMED, THE STENT GOT CAUGHT IN A CALCIFIED LESION AND HAD TO BE RETRIEVED WITH A SNARE. THERE WAS SOME RESISTANCE NOTED BETWEEN THE TIP OF THE SDS AND THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETETED WITH A NON ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED AND NO PATIENT EFFECTS WERE PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    EMAIL RECEIVED FROM THE LEGAL DEPARTMENT AND SENT TO (B)(6) ON (B)(6), 2010. THE PATIENT REPORTED A PERSONAL INJURY CAUSED BY A HOMECHOICE PRO. DEVICE. THE PATIENT REPORTEDLY USED THE HOMECHOICE PRO DEVICE, SERIAL NUMBER (B)(4), FROM (B)(6) 2008 UNTIL APPROXIMATELY (B)(6) 2009. THE PATIENT WAS ADMITTED TO (B)(6) MEDICAL CENTER FOR ABDOMINAL PAIN. ON (B)(6) 2009, THE PATIENT UNDERWENT SURGERY TO CORRECT A HOLE IN HER COLON AND REMOVE THE PERITONEAL DIALYSIS (PD) CATHETER. REPORTEDLY FROM (B)(6) 2008 THE PATIENT COMPLAINED MONTHLY TO THE PHYSICIAN AND NURSES OF THE SHARP PAIN FROM THE HOMECHOICE PRO "SUCKING HARD" WHEN IT FAILED TO SHUT OFF APPROPRIATELY DESPITE ADJUSTMENT MADE TO THE MACHINE AS INSTRUCTED BY THE PD NURSE. THE PATIENT RECEIVED THE URGENT PRODUCT RECALL LETTER DATED 01/12/2010 SENT REGARDING OVERFILL ISSUES WHILE USING THE HOMECHOICE/HOMECHOICE PRO CYCLERS.

    Description of Event or Problem · 1

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R