FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 THERAPY PUMP
MDR report key: 1211253
·
Received October 16, 2008
Report
- Report Number
- 2921482-2008-00334
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 1, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K023062
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO THE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING INCOMING INSPECTION PRIOR TO RELEASE FOR CLINICAL USE, THE PUMP DID NOT ALARM WHEN A PROXIMAL OCCLUSION WAS PRESENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEMSTAR 7 THERAPY PUMP | 80-FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |