FDA Adverse Event
Malfunction
Summary report: N
ALARIS ADMINISTRATION SET
MDR report key: 3170750
·
Received May 22, 2013
Report
- Report Number
- 9616066-2013-00382
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Report Date
- May 3, 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). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS DISCARDED. THE CUSTOMER COMPLAINT OF SET LEAKED FROM SMARTSITE PORT COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS REPORT WAS NOT IDENTIFIED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SMARTSITE PORT WAS LEAKING. A CONTINUOUS PCA INFUSION WAS CONNECTED TO A NORMAL SALINE MAIN LINE. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227380 | ALARIS ADMINISTRATION SET | FPA | CAREFUSION CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT, SN UNK| ALARIS PCA MODULE, SN UNK |