inforMED

*

Received Oct 7, 2014 · Event occurred Oct 2, 2014

Report 4169164 · MDR key 4169164

Device

Generic name

Blood Tubing Set

Manufacturer

Nipro Corporation

Model 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.