FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 3983184
·
Received June 27, 2014
Report
- Report Number
- 9616066-2014-00610
- Event Type
- Malfunction
- Date Received
- June 27, 2014
- Date of Event
- March 26, 2014
- Report Date
- June 4, 2014
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
CUSTOMER REPORTED BACK CHECK VALVE FAILURE DURING SALINE INFUSION. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377248 | ALARIS PUMP MODULE ADMINISTRATION SET | IV INFUSION SET | FPA | CAREFUSION CORP. | 2420-0500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT AND PUMP MODULE, SNS UNKNOWN| SECONDARY ADMIN SET, MODEL# 72213N, LOT UNKNOWN |