FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 4173456
·
Received October 10, 2014
Report
- Report Number
- 1828100-2014-00875
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 19, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE FSR REPLACED THE POD BOARD IN THE PUMP HEAD AND UPDATED SOFTWARE. THE UNIT OPERATED TO MFR'S SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT PART WAS RETURNED TO THE MFR FOR FURTHER EVAL.
Description of Event or Problem · 1
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING NOTICE OF FIELD CORRECTION (NFC) OF THE DEVICE, THE SYSTEM-1 PUMP HEAD IS DEAD AFTER DOZENS OF ATTEMPTS TO LOAD THE 1.40 SOFTWARE. SINCE THE EVENT OCCURRED DURING NFC, THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642670 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS1 (ROLLER PUMP) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 816571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |