FDA Adverse Event
Malfunction
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 1933197
·
Received December 15, 2010
Report
- Report Number
- 1124841-2010-00231
- Event Type
- Malfunction
- Date Received
- December 15, 2010
- Date of Event
- October 29, 2010
- Report Date
- November 30, 2010
- 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 RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, TERUMO IS STILL INVESTIGATING THIS ISSUE AND WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE SHUNT SENSOR LEAKED. THE PRODUCT WAS CHANGED OUT. NO PATIENT INVOLVEMENT AS OCCURRED DURING PRIME. 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 CORP. | CDI510H | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |