FDA Adverse Event
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 2001855
·
Received February 3, 2011
Report
- Report Number
- 1124841-2011-00044
- Date Received
- February 3, 2011
- Date of Event
- December 28, 2010
- Report Date
- February 1, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVAL CODES. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS, THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THREE SHUNT SENSORS LEAKED ON SEPARATE OCCASIONS; HOWEVER, INFO WAS ONLY PROVIDED FOR TWO OF THE EVENTS. THE PRODUCTS WERE CHANGED OUT. THE SURGERIES WERE COMPLETED SUCCESSFULLY AND WITHOUT DELAY. THERE WAS APPROX 1CC OF BLOOD LOSS ON EACH OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI510H | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |