FDA Adverse Event
Malfunction
Summary report: N
AS50
MDR report key: 8713634
·
Received June 19, 2019
Report
- Report Number
- 1416980-2019-03350
- Event Type
- Malfunction
- Date Received
- June 19, 2019
- Date of Event
- May 24, 2019
- Report Date
- June 19, 2019
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K945942
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN AS50 INFUSION PUMP PRESENTED A L000018 (DRIVE MECHANISM SENSORS) ALARM. THIS WAS NOTED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505162 | AS50 | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |