BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1840823 · Received September 22, 2010

    Report

    Report Number
    1423500-2010-03610
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10E10048 AND H10F16050), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 8 X 30 CAROTID STENT IMPLANTED IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (RICA) TARGET LESION. THE REPORT STATED THAT THE PHYSICIAN HAD DIFFICULTY CLOSING/CAPTURING THE 6 MM ANGIOGUARD EMBOLIC FILTER BASKET. THE PHYSICIAN'S NOTES STATED THAT WHILE ATTEMPTING TO REMOVE THE BASKET IT BECAME STUCK AND RE-DEPLOYED IN THE CATHETER. THE PHYSICIAN THEN RE-FLUSHED THE SYSTEM AND WAS ABLE TO SUCCESSFULLY CAPTURE AND REMOVE THE ANGIOGUARD DEVICE. THERE WAS NO DEBRIS NOTED IN THE FILTER BASKET. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT WAS SYMPTOMATIC FOR THE INDEX PROCEDURE. THE RICA TARGET LESION WAS REPORTED TO BE: A 90% STENOSIS, 10 MM LENGTH, 6.0 MM REFERENCE DIAMETER, SEVERELY TORTUOUS, MODERATELY CALCIFIED, AND ECCENTRIC. THE LESION WAS PRE-DILATED. A PRECISE 8 X 30 STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. THE RESIDUAL STENOSIS WAS 0%.

    Description of Event or Problem · 1

    A HOMECHOICE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE TO END THERAPY DURING DWELL 3 OF 4. THE HP STATED SHE NEEDED TO END THERAPY TO GO TO THE HOSPITAL AND DID NOT SAY WHY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN ENDING THERAPY PER THE HP?S REQUEST. THE HOMECHOICE WAS OPERATIONAL. ON (B)(6)2010, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE HP'S PERITONEAL DIALYSIS (PD) NURSE: ON AN UNREPORTED DATE, THE HP STARTED THERAPY WITH LOCAL (PD4) AMBUFLEX. THE HP WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6)2010 AND WAS HOSPITALIZED FROM (B)(6)2010 TO (B)(6)2010. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THIS PERITONITIS EVENT. A CELL COUNT, CULTURE, AND GRAM STAIN WERE PERFORMED ON THE HP'S EFFLUENT ON (B)(6)2010. THE CELL COUNT SHOWED 17700 LEUCOCYTES, THE GRAM STAIN SHOWED MORE THAN 3 WHITE BLOOD CELLS, AND THE CULTURE SHOWED KLEBSIELLA PNEUMONIAE AS THE CAUSATIVE ORGANISM. THE NURSE INDICATED THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAS RECOVERED FROM THE PERITONITIS. THE NURSE INDICATED THE CAUSE OF THE PERITONITIS WAS POOR ASEPTIC TECHNIQUE, AND WAS NOT DUE TO ANY OF THE HP'S BAXTER PD SOLUTIONS OR PD DEVICES. NO FURTHER INFORMATION IS AVAILABLE. THE FOLLOWING ARE POTENTIALLY ASSOCIATED LOTS FOR THIS PERITONITIS EVENT: HOMECHOICE CASSETTE (PRODUCT CODE 5C4531C, LOTS H10E10048 AND H10F16050), MINICAPS (PRODUCT CODE 5C4466P, LOTS GD873901, GD874834, GD874842, GD875559, AND GD875567), TRANSFER SET (PRODUCT CODE 5C4482, LOTS H10A20038 AND H10B25035).

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R LOCAL (PD4) AMBUFLEX