FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3040520
·
Received March 11, 2013
Report
- Report Number
- 1314492-2013-00221
- Event Type
- Malfunction
- Date Received
- March 11, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 11, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL AND THEREFORE AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN UNK AMOUNT OF SPECTRUM PUMPS ARE ALARMING FOR UPSTREAM OCCLUSIONS, WHEN NO OCCLUSIONS ARE OBSERVED. THE CUSTOMER STATED THAT THIS OCCURS FREQUENTLY WITH D5, NORMAL SALINE, MORPHINE AND HEPARIN (PROGRAMMED AMOUNTS AND DELIVERY RATES UNK).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102724 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |