inforMED
InjuryMSB

VIASPAN

Received May 29, 2014 · Event occurred Apr 29, 2014

Report MW5036417 · MDR key 3845950

Device

Generic name

Preservation Fluid

Lot number

16G10043

Product problems

  • Insufficient Device Problem Information

Patient

50 YR

  • Arrhythmia
  • Cardiopulmonary Arrest
  • Low Blood Pressure/ Hypotension
  • Reaction

Narrative

Description of Event or Problem

DURING KIDNEY TRANSPLANT, AFTER PT UNCLAMPED (ORGAN PERFUSED WITH RECIPIENT BLOOD), BLOOD PRESSURE DROPPED AND PT HAD AN ARRHYTHMIA. PT WAS CODED AND FULLY RESUSCITATED AT THIS TIME. PT DID VERY WELL WITH IMMEDIATE FUNCTION OF HER TRANSPLANTED ORGAN. POSSIBLE THAT THE PT HAD A REACTION TO THE PRESERVATION FLUID, VIASPAN. LOT NUMBER WAS 16G10043 AND THE EXPIRATION DATE WAS SEPTEMBER 2014. DIAGNOSIS OR REASON FOR USE: KIDNEY PRESERVATION SOLUTION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.