FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 4002395
·
Received July 9, 2014
Report
- Report Number
- 1828100-2014-00579
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 18, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP DISPLAY WAS BLANK. THE PUMP WAS STILL FUNCTIONAL. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399062 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS 1 (ROLLER PUMP) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |