MalfunctionBTC
ATRIUM ATS BLOOD BAG
Received Jun 14, 2005 · Event occurred Feb 23, 2005
Report 617101 · MDR key 617101
Device
Generic name
Blood Bag
Manufacturer
Atrium Medical CorporationModel number
700 MLCatalog number
*
Lot number
10004475
Product problems
- Self-Activation or Keying
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A SELF FILLING ATS BLOOD BAG, 700 ML VOLUME, WAS SELF INFLATED PRIOR TO PATIENT ATRIUM CONNECTION OR PATIENT USE. TWO OTHERS WITH SAME LOT NUMBER WERE ALREADY INFLATED IN PACKAGE BEFORE USE. THERE WAS NO PATIENT HARM.