NA
Received May 14, 2009 · Event occurred Apr 1, 2009
Report 2090040-2009-00002 · MDR key 1416706
Device
Product problems
- Backflow
- Loss of Power
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER WAS USING A TISSUE STABILIZER IN AN OPEN HEART OFF PUMP PROCEDURE WITHOUT THE CANISTER AND REPORTED THAT BLOOD BACKED UP IN THE TUBING AND THE MACHINE SHUT DOWN. THE PROCEDURE TIME WAS EXTENDED BY 30 MINS. THERE WAS NO PT INJURY OR ADVERSE OUTCOME REPORTED.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO ASCENT HEALTHCARE SOLUTIONS WITHOUT ANY LABELING OR SALES ORDER INFO. THEREFORE, THE LOT NUMBER, MANUFACTURE DATE AND EXPIRATION DATE COULD NOT BE DETERMINED. THE CUSTOMER STATED THAT A CANISTER WAS NOT USED WITH THE STABILIZER BECAUSE THEY DID NOT HAVE ONE THAT FIT THE DEVICE. ASCENT HEALTHCARE SOLUTION'S IFU STATES: "CONNECT OTHER END OF THE NON-FILTER TUBING SET TO A FLUID COLLECTION CONTAINER (NOT SUPPLIED)."