FDA Adverse Event Malfunction Summary report: N

*

MDR report key: 1001303 · Received January 24, 2008

Report

Report Number
1001303
Event Type
Malfunction
Date Received
January 24, 2008
Date of Event
January 9, 2008
Report Date
January 24, 2008
Manufacturer
OR SOLUTIONS, INC.
Product Code
KKX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE OR STAFF WERE SETTING UP FOR A CABG. THE SCRUB TECHNICIAN REPORTED THAT SHE HAD A PUDDLE ON THE FLOOR BEFORE SHE PULLED THE TABLES UP TO THE OPERATIVE FIELD. SHE QUESTIONED THE CIRCULATOR, AND BOTH THOUGHT THAT SOME SALINE MAY HAVE BEEN ACCIDENTALLY POURED ON THE FLOOR WHEN THE SLUSH MACHINE WAS INITIALLY LOADED FOR THE CASE. HOWEVER, DURING THE SURGERY, THE SCRUB TECHNICIAN REPORTED NEEDING MORE SALINE TO MAKE SLUSH. OTHERWISE, THE SURGERY ITSELF WAS UNEVENTFUL. AT THE END OF THE CASE, AS STAFF WERE TAKING THE EQUIPMENT DOWN, STAFF NOTED THAT THERE WAS A HOLE IN THE DRAPE THAT LINED THE SLUSH MACHINE AND THAT SALINE WAS STANDING IN THE MACHINE. UPON CLOSER EXAMINATION, THERE WAS AN AREA AROUND THE DISK IN THE DRAPE THAT WAS STEADILY LEAKING. PER STAFF, NO INSTRUMENTS ARE PLACED IN THE SLUSH MACHINE. STAFF STATE THAT IT IS NOT POSSIBLE THAT AN OR INSTRUMENT OR ANOTHER PIECE OF EQUIPMENT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOLE. NO PATIENT OR STAFF WERE HARMED IN THIS EVENT. THE REP WAS NOTIFIED OF THE EVENT AND HAS ALREADY PICKED UP THE DEVICE. STAFF SUSPECT THAT THE HOLE WAS PRESENT PRIOR TO OPENING THE DRAPE. IN REVIEWING THE EVENT, STAFF ARE CONFIDENT THAT THE SALINE THEY SAW ON THE FLOOR WAS A RESULT OF THE LEAKING DRAPE AND NOT A SPILL.====================== MANUFACTURER RESPONSE FOR STERILE SLUSH DRAPE, (BRAND NOT PROVIDED)======================THE REP WAS CONTACTED ON THE DAY OF THE EVENT, AND CAME TO THE HOSPITAL TO PICK UP THE DEVICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * DRAPE, SLUSH KKX OR SOLUTIONS, INC. * 0907003

Patients

Seq Age Sex Outcome Treatment
1 65 YR