FDA Adverse Event
Death
Summary report: N
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
MDR report key: 6125328
·
Received November 23, 2016
Report
- Report Number
- 2248146-2016-00093
- Event Type
- Death
- Date Received
- November 23, 2016
- Date of Event
- November 2, 2016
- Report Date
- November 23, 2016
- Manufacturer
- DATASCOPE FAIRFIELD
- Product Code
- DSP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT EXPECTED TO RETURN FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).
Description of Event or Problem · 1
ACCOUNT REPORTED THE FOLLOWING: CONTINUED TO SEE "CHECK INTRA-AORTIC BALLOON CATHETER' MESSAGE. PUMP CONTINUED WITH FOLLOWING MESSAGE- "CHECK IABP CATHETER" PATIENTS CONDITION WAS CRITICAL. PATIENT WAS IN FOR A CORONARY ARTERY BYPASS GRAFT PROCEDURE. PATIENT ALSO HAD AORTIC VALVE DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774960 | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE FAIRFIELD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Death |