FDA Adverse Event
Injury
Summary report: N
ALARIS PUMP MODULE IV ADMINISTRATION SET
MDR report key: 2981106
·
Received February 20, 2013
Report
- Report Number
- 9616066-2013-00095
- Event Type
- Injury
- Date Received
- February 20, 2013
- Date of Event
- January 1, 2013
- Report Date
- February 4, 2013
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK FROM THE SMARTSITE VALVE. THE CUSTOMER STATED THE SET HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS REPORT COULD NOT BE IDENTIFIED.
Description of Event or Problem · 1
CUSTOMER REPORTED LEVOPHED HAD BEEN INFUSING FOR 6 HOURS WHEN THE PATIENT'S BLOOD PRESSURE STARTED TO DROP. NURSE NOTICED THE FLOOR WAS WET AND FLUID WAS LEAKING FROM THE SMARTSITE CLOSEST TO THE PATIENT. NO MEDICAL INTERVENTION WAS PERFORMED. A NEW IV TUBING WAS HUNG AND THE PATIENT'S BLOOD PRESSURE CAME BACK UP TO BASELINE. CUSTOMER STATED THAT NO PRODUCT WILL BE RETURNED BECAUSE IT WAS DISCARDED. NO ADDITIONAL PATIENT OR EVENT INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73336 | ALARIS PUMP MODULE IV ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 2426-0500 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | ALARIS PUMP MODULE: SN UNKNOWN| ALARIS PC UNIT: SN UNKNOWN |