FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 4581085
·
Received October 8, 2014
Report
- Report Number
- 1314492-2014-62572
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 1, 2014
- Report Date
- September 25, 2014
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT 200475. THE DOWNSTREAM OCCLUSION ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG RE(B)(4).VIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADDITIONAL INFO IS RECEIVED A FOLLOW UP WILL BE SENT. THE FORCE SENSOR PUSHER, DOWNSTREAM TUBING GUIDE AND FORCE SENSOR GASKET WERE REPLACED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 6 OCCURRENCES OF 'DOWNSTREAM OCCLUSION' ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT 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 |
|---|---|---|---|---|---|---|---|
| 634121 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP. | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |