FDA Adverse Event
Malfunction
Summary report: N
INFUSOR PUMP
MDR report key: 1063838
·
Received June 19, 2008
Report
- Report Number
- 6000001-2008-00383
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- May 23, 2008
- Report Date
- June 3, 2008
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FRN
- PMA / PMN Number
- K926385
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER AT THIS TIME.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A PUMP THAT IS DELIVERING THE INCORRECT DOSAGE. INFORMATION WAS PROVIDED THAT THE PROBLEM OCCURRED BEFORE USING THE PUMP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSOR PUMP | 80FRN | FRN | BAXTER HEALTHCARE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |