FDA Adverse Event
Malfunction
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 3960352
·
Received June 23, 2014
Report
- Report Number
- 1124841-2014-00092
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Date of Event
- June 2, 2014
- Report Date
- June 5, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A F/U REPORT FROM 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 CORPORATION THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE SHUNT SENSOR LEAKED AT THE LARGE BLUE LUER CAP. NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 366080 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI510H | QP09A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |