BEUDAMED
    FDA Adverse Event Summary report: N

    1423500-2010-04254

    MDR report key: 1863420 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04254
    Date Received
    October 11, 2010
    Product Code
    FKX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10E11020 AND H10F15029 WITH NO DEFECTS NOTED. ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION AVAILABLE. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE FIRST OF TWO COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED.THIS EVENT OF DEATH INVOLVES 2BAXTER PRODUCTS; THIS IS REPORT 1 OF 2. BAXTER IS IN THE PROCESS OF INVESTIGATING THIS INCIDENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A US NURSE REPORTED THE EVENTS OF ABDOMINAL PAIN, MULTI-MICROBIAL BOWEL OBSTRUCTION, SEPTICEMIA IN THE BOWELS, PERITONITIS, BOWEL RUPTURE, MYOCARDIAL INFARCTION, AND FATAL CARDIAC ARREST IN AN (B)(6) MALE PATIENT WITH DIANEAL PD2 AMBUFLEX, DIANEAL PD4 AMBUFLEX, AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX, DIANEAL PD4 AMBUFLEX, AND EXTRANEAL VIAFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FACILITY NURSE STATED THAT IN (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR ABDOMINAL PAIN AND SUBSEQUENTLY DIAGNOSED WITH MULTI-MICROBIAL BOWEL OBSTRUCTION. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE HE DEVELOPED SEPTICEMIA IN THE BOWELS THAT PROGRESSED TO PERITONITIS AND BOWEL RUPTURE. ON (B)(6)2010, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND CARDIAC ARREST AND LATER EXPIRED ON THAT DATE. THE CAUSES OF DEATH WERE REPORTED AS SEPTICEMIA IN THE BOWELS, PERITONITIS, BOWEL RUPTURE, MYOCARDIAL INFARCTION, AND CARDIAC ARREST. THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT FOR THE EVENTS PRIOR TO DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. PERITONEAL DIALYSIS THERAPY WAS ONGOING AT THE TIME OF THE PATIENT'S DEATH. THE NURSE INDICTED SEPTICEMIA IN THE BOWELS, PERITONITIS, BOWEL RUPTURE, MYOCARDIAL INFARCTION, AND CARDIAC ARREST WERE NOT RELATED TO PERITONEAL DIALYSIS THERAPY. THIS IS THE MASTER COMPLAINT FOR THE EVENT OF DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE FIRST PROGLIDE WAS DEPLOYED, NO SUTURE WAS RETRIEVED. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. A THIRD PROGLIDE WAS SUCCESSFULLY USED TO ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 DIANEAL PD2 AMBUFLEX, DIANEAL PD4 AMBUFLEX, AND EX