FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3932039
·
Received February 1, 2014
Report
- Report Number
- 1314492-2014-07268
- Event Type
- Malfunction
- Date Received
- February 1, 2014
- Date of Event
- January 1, 2014
- Report Date
- January 14, 2014
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Removal / Correction Number
- 1314492-080712-002-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE REPORTED SYMPTOMS INOPERABLE KEYPAD. EVALUATION FOUND ALL KEYS INOPERABLE DUE TO A STUCK 2ND SOFT KEY CAUSED BY A FAILED INPUT/OUTPUT PRINTED CIRCUIT BOARD. THE INPUT/OUTPUT PRINTED CIRCUIT BOARD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THE ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP WAS AN INOPERABLE KEYPAD. THERE WAS NO REPORTED PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69147 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |