inforMED
MalfunctionKPF

BAXTER PERITONEAL DIALYSIS DIANEAL

Received Nov 30, 2015 · Event occurred Nov 10, 2015

Report 5313841 · MDR key 5313841

Device

Generic name

Pd Fluid Ultrabag

Catalog number

5B9766

Lot number

C992461

Product problems

  • Moisture or Humidity Problem

Patient

73 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING HOME VISIT PATIENT WAS PERFORMING DIANEAL BAG CHECK PRIOR TO EXCHANGE, THE BAG WAS 2000ML 1.5% LOW CALCIUM, WHEN IT WAS NOTED TO HAVE A LARGE AMOUNT OF CONDENSATION INSIDE THE TUBING. FRANGIBLES STILL INTACT. DIANEAL BAG NOT USED, 13 CASES PULLED FROM PATIENT'S HOME STOCK AND RETURNED TO BAXTER.