FDA Adverse Event
Malfunction
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 2993026
·
Received March 1, 2013
Report
- Report Number
- 1124841-2013-00063
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 13, 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
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFORMATION AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT AFTER CARDIOPULMONARY BYPASS SURGERY, IT WAS NOTED THAT THE SHUNT SENSOR HAD LEAKED. VERY MINIMAL BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89508 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI510H | PM15C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |