FDA Adverse Event Injury Summary report: N

PROSORBA COLUMN

MDR report key: 49145 · Received November 8, 1996

Report

Report Number
3023288-1996-00006
Event Type
Injury
Date Received
November 8, 1996
Date of Event
October 8, 1996
Report Date
November 8, 1996
Manufacturer
CYPRESS BIOSCIENCE, INC.
Product Code
LQQ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
AR, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PT WITH CHEMOTHERAPY-INDUCED HUS, END-STAGE CANCER OF COLON, RECEIVED HIS FIRST COLUMN TREATMENT ON 10/8/96. PROCEDURE STARTED WITHOUT INCIDENT. BLOOD PRESSURE (B/P_208/110. AFTER DIVERSION OF HEPARINIZED SALINE TO WASTE, TREATED PLASMA RETURNED TO PT AT 5,L/MN. AFTER 15 MINUTES THE RETURN RATE OF PLASMA TO PT WAS INCREASED TO 10ML/MN. B/P STABLE AT 166/99. APPROX 3 MINUTES AFTER INCREASE IN PLASMA FLOW RATE, THE PT COMPLAINED OF ABDOMINAL FULLNESS AND THEN VOMITED. PROCEDURE STOPPED. BOLUS OF SALINE ADMINISTERED. PT FELT BETTER AFTER APPROX 5 MINUTES AND THE PROCEDURE WAS RESTARTED. AGAIN, WITHIN 2-3 MINUTES THE PT EXPERIENCED VOMITING. THE PROCEDURE AGAIN WAS STOPPED AND THE PT WAS GIVEN SALINE. THE PROCEDURE WAS RESTARTED WITYH REINFUSION RATE OF TREATED PLASMA AT 5ML/MN BUT THE PT WAS UNABLE TO TOLERATE DUE TO ANOTHER EPIDOSE OF VOMITING. PROCEDURE DISCONTINUED. PT RECEIVED 202CC OF TREATED PLASMA. B/P 170/100. THE PT HAS NO RENAL FUNCIOTN AND ES DIALYZED IMMEDIATELY AFTGER COLUMN THERAPY. THE PT WAS ON DIALYSIS FOR APPROX 2/5 HOURS AND THEN COMPLAINED OF ABDOMINAL CRAMPING AN NAUSEA. HE WAS UNABLE TO TOLERATE DIALYSIS FURTHER AND THE PROCEDURE WAS DISCONTINUED. THE PT UNDERWENT HIS SECOND COLUMN TREATMENT THE NEXT DAY, 10/9/96, AND AFTER APPROX 100 CC OF TREATED PLASMA HAD BEEN RETURNED, THE PT EXPERIENCED TIGHTNESS IN HIS CHEST. SHORTNESS OF BREATH, AND COMPLAINED OF NAUSEA. OXYGEN WAS ADMINISTERED. THE PROCEDURE WAS HALTED FOR A SHORT TIME AND THEN RESTARTED, BUT SYMPTOMS CONTINUED AND THE PROCEDURE WAS DISCONTINUED. THE PT WAS TO CONTINUE ON DIALYSIS AND HAVE A THERAPEUTIC PLASMA EXCHANGE ON 10/11/96. THE PT'S CLINICIAN ELECTED TO DISCONTINUE PLASMA EXCHANGE THERAPY ON 10/14/96. NO ADD'L COLUMN TREATMENTS PLANNED AT THIS TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION BOLUM LQQ CYPRESS BIOSCIENCE, INC. NA 061896C

Patients

Seq Age Sex Outcome Treatment
1 39 YR Required Intervention