FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3085775
·
Received April 5, 2013
Report
- Report Number
- 1314492-2013-00363
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 7, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVAL WAS UNABLE TO CONFIRM THE CONSTANT OCCLUSION ALARM. UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE UNIT ALSO PASSED ADDITIONAL UPSTREAM AND DOWNSTREAM OCCLUSION TESTS. NO MALFUNCTION COULD BE IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING A PUMP HAS A CONSTANT UPSTREAM OCCLUSION ALARM. THE TEST WAS PERFORMED WITH LIQUID SALINE AT ROOM TEMPERATURE AND THE PUMP WAS PROGRAMMED TO DELIVER AT A RATE OF 200 ML/HR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141875 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BAXTER SET IV 2C8515 |