FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3173107
·
Received May 30, 2013
Report
- Report Number
- 1314492-2013-00675
- Event Type
- Malfunction
- Date Received
- May 30, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 26, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE PUMP KEYPAD WAS FOUND TO BE CAPABLE OF LIMITED OPERATION DUE TO INTERMITTENTLY RESPONSIVE #2 AND #5 KEYS CAUSED BY EXTERNAL INFLUENCE. THE KEYPAD WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP KEYPAD HAS INOPERABLE #2 AND #5 KEYS. THE CUSTOMER STATED THAT WHEN YOU PUSH ONE BUTTON ON THE DEVICE, THE DEVICE WOULD "TOGGLE TO ANOTHER COMMAND." IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238719 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |