FDA Adverse Event
Malfunction
Summary report: N
PLUM A+3 PUMP MEDNET WIRELESS
MDR report key: 1181088
·
Received September 29, 2008
Report
- Report Number
- 2921482-2008-00303
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 10, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K052052
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTING AND INVESTIGATION FOUND THAT THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THIS WAS DUE TO A BROKEN DISTAL PRESSURE SENSOR PIN TIP.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM A+3 PUMP MEDNET WIRELESS | 80-FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |