BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAYMAR T-PUMP

    MDR report key: 55583 · Received December 11, 1996

    Report

    Report Number
    1313850-1996-00031
    Event Type
    Injury
    Date Received
    December 11, 1996
    Date of Event
    May 23, 1996
    Report Date
    December 10, 1996
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    FOH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAS IV INFILTRATE INTO LEFT HAND ON 5/23/96 RESULTING IN EXTRAVASATION OF MANNITOL INTO HAND TISSUES. THE PT HAD PRE-EXISTING LEFT ARM EDEMA. A HEATING PAD WAS APPLIED TO HAND. EXACT LENGTH OF USE NOT KNOWN. THREE DAYS LATER BLISTERS NOTED ON LEFT HAND. PT REQUIRED FULL THICKNESS SKIN GRAFT ON 7/26/96. SURGEON ASSESSED BURN TO BE THERMAL IN NATURE. THIS REPORT WAS REC'D BY THE MFR 26 AUGUST 1996 ALONG WITH A LETTER STATING THE HOSP WAS NOT CERTAIN OF WHICH PUMP WAS INVOLVED IN THE INCIDENT. IT WAS ALSO STATED THAT THE HOSP WOULD NOIFY THE MFR OF THE BIOMEDICAL ENGINEERING EVAL OF ALL PUMPS. CO HAS NOT REC'D THAT EVAL, BUT CO WILL CONTINUE EFFORTS TO OBTAIN THE RESULTS. 12/10/96, STAFF FROM HOSP STATED DURING PHONE CONVERSATION WITH 2 STAFF FROM CO, THAT EVAL OF TEMPERATURE THERAPY PUMPS WOULD NOT BE COMPLETE UNTIL END OF 2/97. 12/10/96, HOSP CENTER ASK IF AT THIS TIME SHE COULD CONFIRM IDENTITY OF COMPLAINT PUMP. SHE SAID, "ALTHOUGH THEY DON'T KNOW THE SERIAL NUMBER OF THE PUMP AND THEY DO OWN ANOTHER CO'S PUMPS, THE NURSE INVOLVED WAS SURE THE INCIDENT PUMP WAS CO TP200", WHICH RESOLVED INITIAL CONFUSION DURING THE 8/26/96 DISCUSSION WHETHER THE PUMP INVOLVED WAS BELIEVED TO BE ANOTHER CO'S OR A CO PRODUCT. BLISTERING AS A RESULT OF THE PROCEDURE REPORTED IN THE INCIDENT CAN OCCUR IN THE ABSENCE OF HEAT. AT THIS TIME WE HAVE NO INDICATION THAT THE PRODUCT MALFUNCTIONED OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAYMAR T-PUMP TEMPERATURE THERAPY PUMP FOH GAYMAR INDUSTRIES, INC. TP200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention