FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 3943773
·
Received April 30, 2014
Report
- Report Number
- 1828100-2014-00346
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- April 7, 2014
- Report Date
- April 7, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00054. THIS COMPLAINT WAS CONFIRMED BY THE PRODUCT SURVEILLANCE TECHNICIAN. VISUAL INSPECTION OF THE PUMP'S INTERIOR SHOWED DAMAGED FAN WIRES. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO MFR'S SPECS BEFORE BEING RETURNED TO THE CUSTOMER. IF ADD'L INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem · 1
THE PRODUCT SURVEILLANCE TECHNICIAN REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE INTERNAL FAN WIRE WAS DAMAGED. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258354 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS 1 (ROLLER PUMP) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |