FDA Adverse Event
Malfunction
Summary report: N
BODYGUARD
MDR report key: 3952415
·
Received May 14, 2014
Report
- Report Number
- 3006967710-2014-00001
- Event Type
- Malfunction
- Date Received
- May 14, 2014
- Report Date
- April 14, 2014
- Manufacturer
- CME AMERICA LLC
- Product Code
- FRN
- PMA / PMN Number
- K042696
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A REPORT OF THE EVALUATION AND RESULTS WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING ROUTINE INVESTIGATION/TESTING OF A CUSTOMER PUMP AT CME AMERICA, THE BODYGUARD COLORVISION 545 PUMP INFUSION RATE INCREASED TO THE PRIMING RATE (1200 MLS PER HOUR) FOR A FEW SECONDS BEFORE STOPPING AND ALARMING). THE PUMP WAS NOT IN USE ON A PATIENT. THE PUMP WAS LOCATED AT CME AMERICA WHEN THIS PRODUCT PROBLEM WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288198 | BODYGUARD | INFUSION PUMP | FRN | CME AMERICA LLC | COLORVISION 545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |