FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 3023262
·
Received February 27, 2013
Report
- Report Number
- 9616066-2013-00134
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 7, 2013
- Report Date
- February 8, 2013
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT CHEMOTHERAPY LEAKED FROM THE SILICONE SEGMENT AT THE UPPER FITMENT AREA. NO PATIENT/NURSE HARM OR MEDICAL INTERVENTION OCCURRED. THE CUSTOMER STATED THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84967 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |