FDA Adverse Event
Injury
Summary report: N
ALARIS PUMP MODULE
MDR report key: 2477366
·
Received February 29, 2012
Report
- Report Number
- 2016493-2012-00116
- Event Type
- Injury
- Date Received
- February 29, 2012
- Report Date
- February 8, 2012
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K950419
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED IN SECTIONS A AND B. THIS REPORT WAS FILED BY THE MANUFACTURER. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED OCCLUSION BECAUSE THE DEVICE WAS NOT RETURNED. A FAILURE INVESTIGATION COULD NOT BE PERFORMED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE PUMP WILL ALARM FOR AN OCCLUSION BUT BY THAT TIME, THE DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS ALREADY OCCLUDED. THE PROXIMAL PORT HAD SOLUTION INFUSING AT 10ML/HOUR AND THE DISTAL PORT HAD SOLUTION INFUSING AT 55ML/HOUR. THE PROXIMAL PORT OCCLUDED AND NEEDED TO BE FLUSHED WITH TPA TO CLEAR THE LINE. THE INFUSION HAD BEEN RUNNING FOR SOME TIME. CUSTOMER STATES THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE | FRN | CAREFUSION CORPORATION | 8100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention | ALARIS PC UNIT: SN UNKNOWN.| THERAPY DATE UNKNOWN.| DOUBLE LUMEN CVP CATHETER: MODEL/LOT UNKNOWN, |