FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2974891
·
Received February 22, 2013
Report
- Report Number
- 1416980-2013-04527
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- October 11, 2012
- Report Date
- February 7, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION: THE CUSTOMER'S REPORTED PROBLEM OF "UNDETERMINED MALFUNCTION" WAS CONFIRMED AS AN INSERT SLIDE CLAMP ALARM. THE CAUSE OF THE PROBLEM WAS SEDIMENTS OVERSHADOWING THE LIQUID SENSOR. THE SLIDE CLAMP WAS CALIBRATED TO FIX THE PROBLEM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH AN "UNDETERMINED MALFUNCTION. UPON FURTHER INVESTIGATION, THE QUALITY ENGINEER CONFIRMED THE REPORTED CONDITION AS AN INSERT SLIDE CLAMP ALARM. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78537 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |