FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3171708
·
Received June 16, 2013
Report
- Report Number
- 1416980-2013-15474
- Event Type
- Malfunction
- Date Received
- June 16, 2013
- Report Date
- May 21, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS SERVICED AT THE CUSTOMER SITE. FUNCTIONAL TESTING FOUND EVIDENCE OF AN AIR IN LINE ALARM. THE CAUSE WAS DETERMINED TO BE THE AIR IN LINE SENSOR WAS OUT OF CALIBRATION. IN ORDER TO CORRECT THE REPORTED CONDITION THE SENSOR WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD EXPERIENCED A CONSTANT AIR IN LINE ALARM. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. HOWEVER, THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272732 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |