FDA Adverse Event Malfunction Summary report: N

*

MDR report key: 2213929 · Received August 8, 2011

Report

Report Number
2213929
Event Type
Malfunction
Date Received
August 8, 2011
Date of Event
July 16, 2011
Report Date
August 8, 2011
Manufacturer
MAQUET
Product Code
DTL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

WHILE REPOSITIONING PT, THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SPECIALIST WAS HOLDING AND WATCHING THE CANNULAS AND FLOWS. AFTER REPOSITIONING, A PUDDLE OF BLOOD WAS NOTED DOWN THE SIDE OF THE BED AND ON THE FLOOR. THERE WAS BLOOD ON THE CIRCUIT AROUND BOTH SIDES OF THE BRIDGE AND THE MIXED VENOUS OXYGEN SATURATION (SVO2) MONITOR. THE PHYSICIAN WAS CALLED TO THE BEDSIDE. ALL BLOOD WAS CLEANED OFF THE CIRCUIT AND THE CIRCUIT WAS ASSESSED WITH A FLASHLIGHT. NO ADDITIONAL LEAKING WAS NOTED AND ALL CONNECTORS AND STOPCOCKS WERE TIGHT. THE ONLY VISIBLE BLOOD WAS FROM THE WHITE PART OF THE STOPCOCK ON THE ARTERIAL SIDE OF THE CANNULAS (NOT IN THE BLOOD FLOW PATH, BUT OUT THE SIDE OF THE WHITE CIRCLE THE STOPCOCK ROTATES ON). THE PERFUSIONIST WAS CALLED WHO STATED HE HAD SEEN THE SAME THING IN THE SAME PLACE WITHIN THE LAST TWO WEEKS AND CHANGED OUT THE STOPCOCK. BECAUSE THIS STOPCOCK WAS NO LONGER LEAKING, AND THE ENTIRE CIRCUIT WOULD HAVE TO BE CHANGED OUT, IT WAS DECIDED THE LEAST RISK WAS TO LEAVE THE CIRCUIT IN PLACE AND OBSERVE FOR FURTHER LEAKING. THESE TWO LEAKS WERE ON THE POSITIVE SIDE OF THE CIRCUIT IN THE BRIDGE AREA. THE DATE OF THE FIRST LEAKING STOPCOCK IS UNKNOWN, BUT THE STOPCOCK CAME FROM THE SAME LOT NUMBER AS THIS ONE. THE MFR RESPONSE FOLLOWS: THE REP CAME TO THE FACILITY AND BROUGHT SAMPLES OF STOPCOCKS. THEY CHOSE ANOTHER STOPCOCK TO PUT INTO THE CIRCUITS. THE REP WILL BE REPLACING THE STOPCOCKS IN THE NEW CIRCUITS AND SENDING THE REPLACEMENT STOPCOCKS FOR CIRCUITS CURRENTLY IN STOCK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * ECMO CIRCUIT STOPCOCK DTL MAQUET * 13035

Patients

Seq Age Sex Outcome Treatment
1 12 YR