BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMUKIN-D

    MDR report key: 269443 · Received March 9, 2000

    Report

    Report Number
    8021034-1999-00004
    Event Type
    Other
    Date Received
    March 9, 2000
    Date of Event
    March 29, 1999
    Report Date
    April 6, 1999
    Manufacturer
    AMUCHINA S.P.A.
    Product Code
    LRJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    3/29/99, FOUR MINS INTO DIALYSIS, PT HAD SWOLLEN FACE AND BEGAN TO VOMIT. BENADRYL WAS ADMINISTERED. AFTER ONE HR EPINEPHRINE WAS GIVEN AND PT RECOVERED WITH TREATMENT AND WAS CONTINUED TREATMENT. DIALYSIS WAS CONTINUED. 3/31/99, PT EXHIBITED NO REACTION DURING DIALYSIS. 4/2/99, MINOR REACTION OBSERVED AFTER 2 MINS INTO DIALYSIS. BENADRYL WAS ADMINISTERED AND DIALYSIS CONTINUED WITH NO FURTHER COMPLICATIONS. 4/5/99, APROX 5 MINS INTO TREATMENT, PT HAD AN APPARENT ALLERGIC REACTION, FACE AND LIPS WERE SWOLLEN WITH SHORTNESS OF BREATH. TREATMENT WAS GIVEN AND PT RECOVERED. 4/7/99, NO REACTIONS.

    Description of Event or Problem · 2

    ON 3/31/99, PT COMPLAINED OF BURNING SENSATION ON BOTH FEET. THERE WAS NO CHANGE IN BLOOD PRESSURE. PT RECOVERED. NO OTHER REACTIONS WERE NOTED.

    Description of Event or Problem · 3

    3/12/99 - 3/19/99. NEEDLE INFILTRATED ON 3/19/99 AND THE PT RETURNED ON 3/20/99 FOR DIALYSIS. 3/20/99 - FIVE MINS INTO DIALYSIS PT COMPLAINED OF LIGHT-HEADEDNESS AND BEING HOT. BLOOD PRESSURE DROPPED FROM 148/80 (PRE-DIALYSIS) TO 112/54 AND DIALYSIS WAS CONTINUED. 3/22/99 - 3/24/99 NO COMPLICATIONS WERE NOTED. 3/26/99 - TWO MINS INTO DIALYSIS, PT COMPLAINED OF A NUMB FEELING AND HAD A DROP IN BLOOD PRESSURE TO 103/49. DIALYSIS WAS CONTINUED AND PT RECOVERED WITH TREATMENT. 3/26/99 - TWO MINS INTO DIALYSIS, PT COMPLAINED ON NUMB FEELING AND HAD A DROP IN BLOOD PRESSURE TO 103/49. DIALYSIS WAS CONTINUED AND PT RECOVERED WITH TREATMENT. 3/29/99 - NO COMPLICATIONS. 3/31/99 - DROP IN BLOOD PRESSURE, DIALYSIS WAS CONTINUED AND PT RECOVERED WITH TREATMENT. 4/2/99-4/5/99 NO COMPLICATIONS.

    Description of Event or Problem · 4

    TEN MINS INTO DIALYSIS, PT COMPLAINED OF SHORTNESS OF BREATH, FEELING FUNNY AND WAS HOT AND TIRED. OXYGEN AND NORMAL SALINE WERE ADMINISTERED. DIALYSIS WAS CONTINUED AND PT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 5

    TEN MINS INTO DIALYSIS, PT COMPLAINED OF NAUSEA WITH HYPOTENSION. NORMAL SALINE WAS ADMINISTERED, DIALYSIS CONTINUED AND PT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 6

    3/25/99 - APPROX 1 HR INTO DIALYSIS PT EXHIBITED A DROP IN BLOOD PRESSURE. MANNITOL AND NORMAL SALINE WERE ADMINISTERED. THE PT RECOVERED WITH TREATMENT AND DIALYSIS WAS CONTINUED. 3/27/99 - APPROX 1.5 HRS INTO DIALYSIS, BLOOD PRESSURE DROPPED. MANNITOL WAS GIVEN AND DIALYSIS CONTINUED. 3/30/99 - APPROX 3 MINS INTO DIALYSIS PT COMPLAINED OF SHORTNESS OF BREATH AND SWOLLEN THROAT. NORMAL SALINE (400 CC) WAS ADMINISTERED. DIALYSIS WAS DISCONTINUED AFTER 10 MINS OF INITIATION OF THE DIALYSIS. OXYGEN, 50 MG BENADRYL AND 500 MG SOLUMED WAS ADMINISTERED. AFTER 30 MINS THE PT RECOVERED AND WENT HOME. 4/1/99 - DRY PACK DIALYZER WAS USED. THERE WAS NO AMUKIN-D EXPOSURE. PT HAD A DROP IN BLOOD PRESSURE AFTER 1 HR INTO TREATMENT. 4/3/99 - 4/6/99 - NO COMPLICATIONS.

    Description of Event or Problem · 7

    ON 3/25/99, DURING DIALYSIS PT COMPLAINED OF NUMBNESS AND DIZZINESS. DIALYSIS WAS CONTINUED AND PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMUKIN-D DISINFECTANT FOR REPROCESSING LRJ AMUCHINA S.P.A. NA 5041

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other PER DAY.| VANCOMYCIN AND GENTAMYCIN AFTER INSERTION OF NEW| GRAFT. ACE INHIBITOR: CATOPRIL 25 MG THREE TIMES
    2 33 YR Other ZESTRIL 20 MG POQD.
    3 36 YR Other VANCOMYCIN, ACE INHIBITOR VASOTEC 10 MG BY MOUTH| TWICE A DAY.
    4 71 YR Other VANCOMYCIN AND GENTAMYCIN. ACE INHIBITOR ZESTRIL| 20 MG ONCE A DAY.
    5 40 YR Other 10 MG TWICE A DAY.| VANCOMYCIN AND GENTAMYCIN ACE INHIBITOR - ZESTRIL
    6 25 YR Other ACCUPRIL 40MG TWICE A DAY.| 2/25/99: AMOXICILLIN FOR 10 DAYS ACE INHIBITOR
    7 57 YR Other ACE INHIBITOR ZESTRIL 20 MG BY MOUTH ONCE A DAY.