FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3062599
·
Received March 18, 2013
Report
- Report Number
- 1314492-2013-00257
- Event Type
- Malfunction
- Date Received
- March 18, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 18, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE EVALUATION CONFIRMED THE UPPER AND LOWER ULTRASONIC SENSOR READINGS TO BE OUT OF SPECIFICATION. THIS WILL CONTRIBUTE TO FALSE UPSTREAM OCCLUSION ALARMS. THE ULTRASONIC SENSORS WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP ALARMS FOR AN UPSTREAM OCCLUSION WHEN NO OCCLUSION WAS PRESENT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY. THE CUSTOMER STATED THAT THE PUMP WAS TESTED AND MULTIPLE UPSTREAM OCCLUSION ALARMS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111642 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |