FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 2904421
·
Received November 30, 2012
Report
- Report Number
- 1314492-2012-00462
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Report Date
- November 1, 2012
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND ALL KEYS PERFORMED AS EXPECTED AND NO KEYS RESULTED IN AN INCORRECT RESPONSE OR DOUBLE ENTRY. FURTHER EVALUATION FOUND A CARBON BUILD UP ON THE #5 KEY; THIS COULD CREATE A SHORT RESULTING IN AN ADDITIONAL INPUT OF THE #5 KEY WHEN ANY OTHER KEY IS SELECTED. SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
A SPECTRUM PUMP WAS RETURNED TO THE CUSTOMER'S BIOMEDICAL DEPARTMENT FOR "STICKING" KEYS. HOWEVER, WHEN THE PUMP WAS TESTED IN THE BIOMEDICAL DEPARTMENT, "STICKING" KEYS WERE NOT OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |