FDA Adverse Event Injury Summary report: N

STERIS 5085 GENERAL SURGICAL TABLE

MDR report key: 2243954 · Received September 6, 2011

Report

Report Number
MW5022152
Event Type
Injury
Date Received
September 6, 2011
Date of Event
September 3, 2011
Report Date
September 6, 2011
Manufacturer
STERIS CORP.
Product Code
FQO
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PT HAD A HISTORY OF INTERSTITIAL LUNG DISEASE AND CORONARY ARTERY BYPASS SURGERY WAS BROUGHT TO THE OPERATING ROOM FOR A LUNG TRANSPLANT VIA LEFT THORACOTOMY WITH CARDIOPULMONARY BYPASS. THE PT WAS PLACED ON THE OPERATING ROOM TABLE IN A SUPINE POSITION, WITH LEFT SIDE BUMPED UP AND ARMS AT SIDES. TO FACILITATE THE ANASTOMOSIS DURING THE CASE THE PT WAS PLACED IN TRENDELENBURG POSITION AND THE TABLE ROTATED TO THE RIGHT TO OPTIMIZE EXPOSURE. FOLLOWING SUCCESSFUL ANASTOMOSIS VARIOUS MANEUVERS INCLUDING RESETTING THE ELECTRONICS OF THE TABLE TO RETURN TO A LEVEL MIDLINE POSITION WERE UNSUCCESSFUL. THE TABLE HAD MALFUNCTIONED AND COULD NOT ROTATE BACK. CLINICAL ENGINEERING, HAVING DEALT WITH A PREVIOUS SIMILAR INCIDENT ASSISTED IN MANUALLY LIFTING THE TABLE TO REDUCE THE WEIGHT WHICH FACILITATED ELECTRONIC TABLE LEVELING. THE EVENT ADDED APPROXIMATELY AN HR TO THE CASE DURING WHICH TIME THE RIGHT RADIAL ARTERIAL LINE BECAME OCCLUDED AND NONFUNCTIONAL. ALSO NOTED FOLLOWING THE EVENT, A SIGNIFICANT PORTION OF THE PULMONARY ARTERIAL ANASTOMOSIS HAD BECOME DISRUPTED LIKELY FROM HIGH PRESSURES DURING THE PERIOD OF TIME DESCRIBED. ULTIMATELY ANOTHER ARTERIAL LINE WAS PLACED, REPAIR OF THE ANASTOMOSIS COMPLETED, AND THE PT WEANED FROM CARDIOPULMONARY BYPASS. DATES OF USE: (B)(6) 2011.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STERIS 5085 GENERAL SURGICAL TABLE GENERAL SURGICAL TABLE FQO STERIS CORP. 5085SRT

Patients

Seq Age Sex Outcome Treatment
1 67 YR Hospitalization| S