BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1873170 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04575
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT INVOLVES FIVE BAXTER PRODUCTS. THIS MEDWATCH IS BEING SUBMITTED FOR THE THIRD OF THOSE FIVE PRODUCTS. AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (3L TIME'S FOUR EXCHANGES NIGHTLY WITH A LAST FILL OF 3L) AND DIANEAL PD4 ULTRABAG (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). THE NURSE STATED THAT SHE DID NOT ANY FURTHER INFORMATION REGARDING THE EVENT OF PERITONITIS TO REPORT. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF ABDOMINAL DISCOMFORT, SHORTNESS OF BREATH, NAUSEA, VOMITING, FEELS OVERFILLED, COLD SWEAT, AND PERITONITIS. PER THE HOME PATIENT'S WIFE, THERE WAS NO BREAK IN ASEPTIC TECHNIQUE. THE PATIENT RECOVERED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOTS (GD877266, GD874842, GD876482) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE REPRESENTATIVE (TSR) TO REPORT FEELING OVERFILLED DURING THE FIRST DWELL CYCLE OF THERAPY. THE TSR HAD THE HP STOP THE DWELL AND BEGIN A MANUAL DRAIN. THE TSR REVIEWED THE PROGRAMMING AND PERFORMED TROUBLE SHOOTING METHODS. THIS REPORT DID NOT MEET OVERFILL CRITERIA AND IS NOT CONSIDERED AN OVERFILL EVENT. THE HP EXPERIENCED NAUSEA, VOMITING AND ABDOMINAL DISCOMFORT ALONG WITH SHORTNESS OF BREATH AND A COLD SWEAT. THE TSR ADVISED THE HP TO CALL 911 OR GO TO THE EMERGENCY ROOM AND ASSISTED WITH AN EMERGENCY DISCONNECT FROM THE HOMECHOICE DEVICE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOME PATIENT'S NURSE ON (B)(4) 2010: THE PATIENT WAS DIAGNOSED AND TREATED FOR PERITONITIS WHEN HE WENT TO THE EMERGENCY ROOM. HE WAS NOT TREATED OR DIAGNOSED WITH OVERFILL. THE NURSE DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING THE PERITONITIS BECAUSE SHE DID NOT HAVE THE PATIENT'S CHART. THE NURSE DID STATE THAT THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R MAG OX, ASA| COREG| LIPITOR| VITAMINS| GLIPIZIDE| OMEPRAZOLE| WARFARIN| RENVELA| FOLIC ACID