inforMED
MalfunctionFOS

GESCO

Received Sep 19, 2014 · Event occurred May 2, 2014

Report 4124574 · MDR key 4124574

Device

Generic name

Catheter, Peritoneal Dialysis, Single Use

Model number

N/A

Catalog number

4000527

Lot number

1130033

Product problems

  • Break

Patient

10 DAY

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

NICU RN REPORTED THAT THE STOPCOCK TO (B)(6) GESCO SYSTEM (LOT #1130033) HAD "BROKEN OFF." AT THE BEDSIDE IT WAS SEEN THAT THE ENTIRE STOPCOCK HAD COME OFF THE SYSTEM. MD NOTIFIED, PERITONEAL DIALYSATE CULTURES DRAWN, AND A NEW GESCO SYSTEM WAS INITIATED.