FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 4853179
·
Received June 18, 2015
Report
- Report Number
- 9616066-2015-00795
- Event Type
- Malfunction
- Date Received
- June 18, 2015
- Report Date
- June 8, 2015
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: INITIAL REPORTER ADDRESS.
Additional Manufacturer Narrative · 1
ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED BALLOONED PUMP SEGMENT. ALTHOUGH REQUESTED; NO ADDITIONAL EVENT INFORMATION PROVIDED. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396454 | ALARIS PUMP MODULE ADMINISTRATION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | 2420-0500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |