FRESENIUS
Received Oct 23, 2009
Report MW5013183 · MDR key 1517746
Device
Product problems
- Material Discolored
- Overheating of Device
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
WE ARE A DIALYSIS CLINIC THAT PURCHASED 21 FRESENIUS 2008K MACHINES IN 2008. WE OBSERVED THAT THE CLEAR PLASTIC POWER PLUGS ON THE POWER CORDS WERE TURNING TO A BROWN, BURNT COLOR AND THAT THE PLUGS WERE GETTING WARM TO THE TOUCH. WE DID NOT OBSERVE THIS PROBLEM AT ALL WITH THE OLDER MACHINES WE HAVE, WHICH ARE THE FRESENIUS 2008H MODEL WHICH HAD A DIFFERENT STYLE OF POWER CORD. THIS PROBLEM WAS REPORTED TO FRESENIUS EARLY THIS YEAR, AND WE SENT THEM SEVERAL SAMPLE CORDS WITH THE BURNT PLUGS, WHICH THEY FORWARDED TO ELECTRI-CORD. FRESENIUS ALSO SENT US 21 REPLACEMENT CORDS, BUT THEY WERE THE EXACT SAME TYPE AS THE ORIGINALS. THIS SAME CORD IS ALSO SUPPLIED AS A SPARE PART. WHEN WE INSTALLED THIS CORD ON AN OLDER 2008H MACHINE, THE SAME THING HAPPENED - THE PLUG TURNED BROWN. THIS CORD LOOKS IDENTICAL TO THE CORD PICTURED IN THE FDA ELECTRI-CORD POWER CORD INVESTIGATION AND HOSPIRA RECALL. BESIDES THE BLACK PLASTIC BRIDGE, THIS NEWER CORD ALSO HAS CRIMPED CONNECTIONS, AS OPPOSED TO THE OLDER CORD WHICH HAD SOLDERED CONNECTIONS IN THE PLUG.