FDA Adverse Event
Malfunction
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 3102626
·
Received May 1, 2013
Report
- Report Number
- 1124841-2013-00099
- Event Type
- Malfunction
- Date Received
- May 1, 2013
- Date of Event
- April 7, 2013
- Report Date
- April 15, 2013
- 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO WILL BE SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS, THE SHUNT SENSOR LEAKED. LESS THAN 1CC BLOOD LOSS. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190677 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI510H | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |