FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUM
MDR report key: 4422125
·
Received May 19, 2014
Report
- Report Number
- 1314492-2014-31681
- Event Type
- Malfunction
- Date Received
- May 19, 2014
- Date of Event
- April 1, 2014
- Report Date
- May 2, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF (B)(4). THE AIR-IN-LINE ALARMS WERE CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP WILL BE SENT. THE ULTRASONIC PUSHER AND ULTRASONIC SENSOR WERE REPLACED.
Description of Event or Problem · 1
DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 37 OCCURRENCES OF ¿AIR-IN-LINE¿ ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN SINCE THESE ITEMS WERE FOUND DURING EVALUATION OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298189 | SPECTRUM INFUSION PUM | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |