SYNTHESIS P.H.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
Received Jun 24, 2014 · Event occurred Jun 2, 2014
Report 1718850-2014-00191 · MDR key 3902381
Device
Generic name
Oxygenator, Cardiopulmonary Bypass
Manufacturer
Sorin Group ItaliaModel number
NACatalog number
050234
Lot number
1402110125
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
44 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SORIN GROUP (B)(4) MANUFACTURES THE SYNTHESIS P.H.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE CLINICIAN NOTED THAT THE WATER IN THE HEATER/COOLER HAD A PINK TINGE TO IT DURING TEAR DOWN OF THE CIRCUIT UPON COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
SORIN GROUP RECEIVED A REPORT THAT THE CLINICIAN NOTED THAT THE WATER IN THE HEATER/COOLER HAD A PINK TINGE TO IT DURING TEAR DOWN OF THE CIRCUIT UPON COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.
Remedial action
- Other