FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3032163
·
Received March 7, 2013
Report
- Report Number
- 1314492-2013-00214
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 7, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP ALARMED FOR AN UPSTREAM OCCLUSION WHILE DELIVERING VASOPRESSIN TO A PATIENT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98392 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BAXTER (B)(4) CLEARLINK DUO-VENT C-FLO SET 10 DPM| VENTED SPIKE ADAPTER| 3 LUER ACTIVATED VALVES| DUO-VENT| BAXTER (B)(4) CONTINU - FLO SOLN. SET |