BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 PRONG ADULT CYCLER 90/2

    MDR report key: 267051 · Received March 2, 2000

    Report

    Report Number
    8030665-2000-00045
    Event Type
    Injury
    Date Received
    March 2, 2000
    Date of Event
    February 4, 2000
    Report Date
    February 9, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    KPF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT CAME BY TELEPHONE FROM PD NURSE. THE COMPLAINNANT REPORTED "THE PUMP SEGMENT, NEXT TO THE HEATER PLATE, TORE OPEN AND FLOODED THE MACHINE WITH SOLUTION". THE CUSTOMER/COMPLAINANT WAS CALLED ON 02/04/2000 AND 02/07/2000 TO OBTAIN FURTHER COMPLAINT INFO. TELEPHONE MESSAGES LEFT. ON 02/09/2000 REP DID MAKE CONTACT WITH THE CLINIC AND SPOKE WITH ANOTHER NURSE. NURSE REPORTED THAT THERE WERE 2 PROBLEMS WITH THIS PRODUCT. THE FIRST WAS THE ABOVE DESCRIBED LEAK FROM THE PUMP SEGMENT. COULD NOT VERIFY WITH THE NURSE IF THE SOURCE OF THE LEAK WAS A TEAR, A HOLE OR A SEPARATION. THE COMPLAINT SAMPLE WAS SAVED, HOWEVER THE RN CUT THE AREA OF THE LEAK FROM THE REMAINDER OF THE TUBING SET FOR EXAMINATION. SAMPLE HAS BEEN REQUESTED. THE SECOND PROBLEM REPORTED ENTERED IS ANOTHER PIR (200000170). PT INFO REQUESTED AS THE LEAK OCCURRED DURING PT USE. THE PT WAS GIVEN PROPHYLACTIC ANTIBIOTIC. THERE WERE NO ADVERSE EFFECTS DUE TO THE LEAK AS REPORTED BY THE NURSE. MDR FILED DUE TO MEDICAL INTERVENTION ADMINISTERED. 0N 02/10/2000, REQUESTED INFO FROM CUSTOMER RETURNED. THE PT REC'D KEFLEX 2GM. ALSO REPORTED WAS THAT THE PT DEVELOPED ITCHING AFTER INSTILLATION OF KEFLEX AND BENADRYL WAS GIVEN WITH RELIEF. ON 03/02/2000 REP CALLED CLINIC AS FOLLOW-UP. NURSE REPORTS THAT THERE HAVE NOT BEEN ANY OTHER SIMILAR LEAKS WITH THIS PRODUCT OR OTHER PROBLEMS. ADDITIONALLY, THE PT HAS BEEN STABLE WITHOUT SIGNS OR SYMPTOMS OF A RELATED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12 PRONG ADULT CYCLER 90/2 PERITONEAL CYCLER TUBING SET KPF ERIKA DE REYNOSA NA R9A817

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other 90/2 CYCLER.