FDA Adverse Event
Malfunction
Summary report: N
PLUM 1.6 PUMP
MDR report key: 1181646
·
Received September 30, 2008
Report
- Report Number
- 2921482-2008-00306
- Event Type
- Malfunction
- Date Received
- September 30, 2008
- Date of Event
- September 9, 2008
- Report Date
- September 9, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K911401
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT ALARM WHEN DISTAL AIR WAS PRESENT. THIS WAS DUE TO THE BUBBLE SENSOR PRINTED CIRCUIT BOARD. THE EVENT THAT IS BEING REPORTED WAS NOTED DURING MANUFACTURING TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE.
Description of Event or Problem · 1
DURING VERIFICATION TESTING, AIR WAS NOTED IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM 1.6 PUMP | 80 - FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |