FDA Adverse Event
Malfunction
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 1845046
·
Received September 13, 2010
Report
- Report Number
- 1124841-2010-00128
- Event Type
- Malfunction
- Date Received
- September 13, 2010
- Date of Event
- August 17, 2010
- Report Date
- September 8, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- 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 EVALUATION, THUS CODES HAVE BEEN CITED. TERUMO WILL SUBMIT A FOLLOW-UP REPORT ONCE THE DEVICE IS RECEIVED AND HAS BEEN EVALUATED. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE SHUNT SENSOR LEAKED. THE UNIT WAS NOT CHANGED OUT, THERE WAS A SLIGHT AMOUNT OF BLOOD LOSS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | CDI510H | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |