FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 THERAPY PUMP
MDR report key: 1002611
·
Received February 8, 2008
Report
- Report Number
- 2921482-2008-00046
- Event Type
- Malfunction
- Date Received
- February 8, 2008
- Date of Event
- January 1, 2007
- Report Date
- January 15, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K023062
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THE DEVICE DELIVERED LESS SOLUTION THAN INTENDED. THE DEVICE WAS RETURNED TO THE USER FACILITY FROM THE HOMECARE PT'S HOME WITH A REPORT THAT THE DEVICE "UNDER INFUSED". NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. ON AN UNSPECIFIED DATE DURING TESTING AT THE USER FACILITY, THE DEVICE DELIVERED LESS THAN EXPECTED. IN 2008 DURING SUBSEQUENT TESTING, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFO 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 | UNK |