FDA Adverse Event Death Summary report: N

AMSCO

MDR report key: 1620170 · Received March 1, 2010

Report

Report Number
1620170
Event Type
Death
Date Received
March 1, 2010
Date of Event
February 24, 2010
Report Date
March 1, 2010
Manufacturer
STERIS CORPORATION
Product Code
FQO
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MD, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PATIENT'S WEIGHT WAS REPORTED AS 355 POUNDS BUT STAFF THOUGHT HE MAY HAVE BEEN LARGER. THE TABLE MAX WEIGHT IS 400 LBS. TABLE EXTENDERS WERE PLACED GIVEN THE PATIENT'S SIZE. THE OPERATING ROOM TABLE WAS TILTED SLIGHTLY TO THE RIGHT. THE PATIENT WAS IN A LATERAL POSITION WITH LEFT SIDE UP. DURING THE OPERATION THE RENAL ARTERY WAS NICKED AND THE PATIENT WAS HEMORRHAGING AS THE SURGEON WAS UNABLE TO CLAMP THE ARTERY. THEY COULD NOT GET THE TABLE INTO A SUPINE POSITION TO BEGIN CHEST COMPRESSIONS AND CONVERTED TO AN OPEN PROCEDURE. THE TABLE WOULD ONLY TILT FURTHER IN THE WRONG DIRECTION. STAFF REPORTED THAT THE MOTOR SOUNDED AS IF IT WAS TRYING TO TURN THE BED (GRINDING/WINDING SOUND) BUT COULD NOT. FOUR DIFFERENT PROVIDERS ATTEMPTED TO CORRECT THE POSITION USING THE BED'S HAND CONTROL. WHEN THEY PRESSED THE LEFT TILT BUTTON OR THE LEVEL BUTTON THE BED WOULD NOT MOVE. IF THE RIGHT TILT BUTTON WAS PRESSED THE PATIENT WENT FURTHER TO THE RIGHT. THE STAFF WAS UNABLE TO REACH THE AUXILLARY OVERRIDE SWITCHES DUE TO THE TABLE'S TILTED POSITION. THE PATIENT WAS HELD ON THE TABLE BY THE OR STAFF AND THEN TRANSFERRED TO A DIFFERENT TABLE SO THAT CPR COULD CONTINUE. CPR WAS DELAYED 3-4 MINUTES DUE TO THE TABLE MALFUNCTION. THE PATIENT DID NOT SURVIVE. THE HEALTHCARE PROVIDER DID NOT THINK THE PATIENT'S HEART WOULD HAVE BEEN ABLE TO HANDLE THE ARREST, NOR EXPECT THE PATIENT TO SURVIVE EVEN IF EVERYTHING HAD BEEN DONE PERFECTLY ALTHOUGH THE TABLE DID INITIALLY DELAY EFFECTIVE RESUSCITATION WHICH DID NOT HELP THE PATIENT'S OUTCOME. THE OFFICIAL CAUSE OF DEATH IS INTRA-OPERATIVE HEMORRHAGE. THE PATIENT'S ESTIMATED BLOOD LOSS WAS 8 LITERS. THE PATIENT RECEIVED 11 UNITS OF PACKED RED BLOOD CELLS DURING THE PROCEDURE. MANUFACTURER RESPONSE (AS PER REPORTER) FOR OPERATING ROOM TABLE, AMSCO SURGICAL TABLETHE MANUFACTURER CAME AND TESTED THE BED. THEY COULD NOT FIND ANYTHING WRONG WITH IT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AMSCO TABLE, OPERATING FQO STERIS CORPORATION 3080 *

Patients

Seq Age Sex Outcome Treatment
1 63 YR Death