MalfunctionNKO
SYSTEM, BALLOON, INTRA-AORTIC, ACCESSORY
Received Oct 25, 2016 · Event occurred Jun 7, 2016
Report 6053622 · MDR key 6053622
Device
Generic name
System, Balloon, Intra-aortic, Accessory
Manufacturer
Datascope CorporationCatalog number
0684-00-0479-02U
Product problems
- Hole In Material
Patient
80 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE TUBING FOR IABP IS SUPPOSED TO HAVE GAS IN IT. BLOOD WAS IN THE TUBING INDICATING THAT THE TUBING MAY HAVE HAD A HOLE IN IT. THERE WAS NO PATIENT INJURY.