*
Received Oct 7, 2014 · Event occurred Oct 2, 2014
Report 4169164 · MDR key 4169164
Device
Generic name
Blood Tubing Set
Manufacturer
Nipro CorporationModel number
*Catalog number
A209Y/V803
Lot number
*
Product problems
- Device Operates Differently Than Expected
Patient
64 YR
- Syncope
Narrative
Description of Event or Problem
PATIENT ATTACHED TO DIALYSIS MACHINE FOR TEN MINUTES. RN AT HER SIDE STATED SHE "WENT OUT" AND HAD A SYNCOPAL EPISODE THAT LASTED 30 SECONDS. A RAPID RESPONSE WAS CALLED AND SHE WAS TRANSFERRED INTO THE ICU. DIALYSIS MACHINE AND DISPOSABLES TAKEN OUT OF SERVICE.THEY ARRIVED TODAY TO DO PM ON THE DIALYSIS MACHINE AND IT WAS CLEARED FOR USE. THEY ALSO TOOK A REPORT TO THE FDA.