BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1936304 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07174
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE FIRST OF TWO COMPLAINTS ASSOCIATED WITH THIS EVENT. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS, (H10H10018 AND H10H31048), AND NO DEFECTS WERE NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ASSIGNABLE CAUSE OF THE REPORTED PROBLEM OF PERITONITIS WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS EVENT INVOLVES TWO BAXTER PRODUCTS. THIS MEDWATCH IS BEING SUBMITTED FOR THE FIRST OF THOSE TWO PRODUCTS.

    Description of Event or Problem · 1

    ON (B)(4) 2011, BAXTER SPOKE TO AN RN AT (B)(6) WHO REPORTED IN (B)(6) 2010, THE HP WAS A CLIENT THERE, BUT ON (B)(6) 2010 HE WAS DISCHARGED. THE HP HAD SEEN A DOCTOR AT (B)(6) DIALYSIS CLINIC IN (B)(6) AND WAS REQUESTING TRANSFER OF CARE. ON (B)(4) 2010, BAXTER SPOKE TO THE NEXT RN AT (B)(6) WHO STATED THAT THE HP HAD AN IN HOME EVALUATION ON (B)(6) 2010 FOR THE CLINIC ADMISSION. ON (B)(6) 2010, AFTER ROUTINE LABS WERE DRAWN (THE RESULTS REMAIN UNREPORTED FROM THE LAB), THE HP NEVER RETURNED TO THE CLINIC. THE (B)(6) RN RECEIVED REPORTS THAT THE HP HAD SOUGHT EMERGENCY CARE AND WAS ADMITTED TO (B)(6) HOSPITAL WITH PERITONITIS ON (B)(6) 2010, SIGNED HIMSELF OUT AGAINST MEDICAL ADVICE ON (B)(6) 2010, AND WAS HOSPITALIZED AGAIN (B)(6) 2010 AT A (B)(6) HOSPITAL FOR THE ONGOING PERITONITIS (DISCHARGE DATE UNKNOWN). THE HP WAS NOT REPORTED AS A CLIENT AT ANY OTHER DIALYSIS CLINIC OR HOSPITAL UNTIL THE RN AT (B)(6) CLINIC RECEIVED A REPORT OF ANOTHER HOSPITALIZATION ON (B)(6) 2010 AT (B)(6) HOSPITAL IN (B)(6), DIAGNOSIS OF RECURRENT PERITONITIS. BAXTER THEN SPOKE TO AN RN AT (B)(6) WHO DID NOT KNOW THE HP'S DISCHARGE DATE OR WHERE HE WENT AFTER THE (B)(6) ADMISSION. THE HP WAS HOSPITALIZED ON (B)(6) 2010 FOR RECURRENT PERITONITIS, THEN DISCHARGED INTO THE CARE OF (B)(6) ON (B)(6) 2010.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS NURSE REPORT FROM THE USA OF TREATMENT NONCOMPLIANCE, PERITONITIS AND BOWEL PROBLEMS IDENTIFIED AS DIARRHEA. THE PATIENT WAS TRANSFERRED TO THE CLINIC ONE MONTH AGO AND HAS BEEN NONCOMPLIANT. ON AN UNREPORTED DATE IN 2010, THE PATIENT BEGAN USING OVER THE COUNTER LAXATIVES (EXACT TYPE UNKNOWN). IN (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND THE BOWEL PROBLEMS. THE CAUSE OF THE PERITONITIS AND BOWEL PROBLEMS WAS THE USE OF THE OVER THE COUNTER LAXATIVES. TREATMENT INFORMATION WAS NOT PROVIDED. IT WAS NOT REPORTED WHETHER DIANEAL AND OVER THE COUNTER LAXATIVES TREATMENT CONTINUED. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAD RECOVERED. PER THE NURSE, THE EVENTS OF BOWEL PROBLEMS AND PERITONITIS WERE NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R OVER THE COUNTER LAXATIVES AND DIANEAL PD4 AMBU-FL