FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 THERAPY PUMP
MDR report key: 1060808
·
Received June 12, 2008
Report
- Report Number
- 2921482-2008-00187
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- January 1, 2008
- Report Date
- May 6, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K060806
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT THE PT RECEIVED LESS MEDICATIONS THAN INTENDED. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPT WITH AN UNSIGNED NOTE THAT STATED, "PUMP SAYS EMPTY BUT MEDICATION IS ALMOST FULL." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO INCLUDING PT OUTCOME.
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 | UNK |