FDA Adverse Event
Other
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1644724
·
Received March 26, 2010
Report
- Report Number
- 1828100-2010-00154
- Event Type
- Other
- Date Received
- March 26, 2010
- Date of Event
- February 25, 2010
- Report Date
- March 26, 2010
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
UPON RECEIPT OF THE DEVICE, THE USER DISCOVERED THAT ROLLER PUMP (B) (4) WAS SENT IN A BOX LABELED FOR A ROLLER PUMP (B) (4). NO ISSUE WAS REPORTED WITH THE ACTUAL FUNCTION OF THE ROLLER PUMP. THIS REPORT IS BEING SUBMITTED DUE TO THE MISLABELING OF THE DEVICE. THERE WAS NO PT INVOLVEMENT DURING 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 | 801040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |