FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE
MDR report key: 10456793
·
Received August 26, 2020
Report
- Report Number
- 2016493-2020-03309
- Event Type
- Malfunction
- Date Received
- August 26, 2020
- Report Date
- August 6, 2020
- Manufacturer
- CAREFUSION
- Product Code
- FRN
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THEY REPLACED AIL, REAR CASE, BEZEL, FRONT CASE, NON ALARIS IUI. THE PROXIMATE CAUSE OF THE REPORTED ISSUE WAS DUE TO CUSTOMER DAMAGE OF THE AIL SENSOR ASSY FOR CORROSION. A REVIEW OF THE DEVICE HISTORY RECORD FOR S/N (B)(4) WAS PERFORMED FROM 6/21/2005 TO 8/20/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXPERIENCED ERROR CODES/MESSAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 917688 | ALARIS PUMP MODULE | PUMP, INFUSION | FRN | CAREFUSION | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |