FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3071134
·
Received April 8, 2013
Report
- Report Number
- 1314492-2013-00367
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 11, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. REVIEW OF THE DEVICE HISTORY LOG CONFIRMS THE PUMP ALARMED MULTIPLE TIMES FOR AIR-IN-LINE. THE EVALUATION CONFIRMED THE LOWER READING OF THE ULTRASONIC SENSOR TO BE BELOW SPECIFICATION. WITH A LOW ULTRASONIC SENSOR READING THE PUMP WILL BECOME MORE SENSITIVE TO AIR AND UPSTREAM OCCLUSION ALARMS. THE FAILED ULTRASONIC SENSOR WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP ALARMED CONSTANTLY FOR "AIR-IN-LINE" WHEN NO AIR BUBBLES WERE OBSERVED. THE CUSTOMER STATED THAT THE DEVICE WAS TESTED AND THE CONSTANT ALARM WAS CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144360 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |