BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1823379 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03094
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS IDENTIFIED THAT THE PATIENT WAS (B)(6) OLD AT THE TIME OF THE EVENT (PREVIOUSLY REPORTED AS (B)(6) OLD). IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE REVEALED POSITIVE FOR (B)(6). IT WAS UNKNOWN IF TREATMENT WAS PROVIDED. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS WITH CULTURE POSITIVE FOR (B)(6). THE NURSE BELIEVED THE PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS UNRELATED TO PERITONEAL DIALYSIS THERAPY.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR THE SUSPECT LOT NUMBER (GD875567), WITH NO DEFECTS NOTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A (B)(6) FEMALE. ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. IN 2010, THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. IT WAS UNKNOWN IF A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. IT WAS UNREPORTED WHETHER TREATMENT WAS PROVIDED. IT WAS UNREPORTED WHETHER PERITONEAL DIALYSIS THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A CHECK SUPPLY LINE ALARM ON THE HOMECHOICE (HC) MACHINE DURING PRIMING. THE HOME PATIENT (HP) STATED THAT THE SPIKE WAS NOT ALL THE WAY IN. THE HP PRESSED GO AND STATED THAT THE HC IS NOW PRIMING. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2010. ACCORDING TO THE PATIENT THERE WERE NO DEFECTS IN THE SPIKE OR THE BAG PORT. THE PATIENT STATED THAT IT WAS HER FAULT AS SHE DID NOT REALIZE THAT SHE DIDN'T SPIKE THE BAG ALL THE WAY. THE PATIENT STATED SHE PUSHED THE SPIKE AND RESUMED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING A PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE PFR KIT (PROCEDURE DATE AND TYPE OF PINNACLE KIT UNKNOWN), THE PATIENT PRESENTED WITH EROSION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R DIANEAL AMBUFLEX