FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1881323
·
Received October 7, 2010
Report
- Report Number
- 1828100-2010-01667
- Event Type
- Malfunction
- Date Received
- October 7, 2010
- Date of Event
- September 13, 2010
- Report Date
- October 7, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED ONE SPRING ON THE TUBING CLAMP ASSEMBLY WAS BROKEN. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | ROLLER PUMP | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 816571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |