FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS EXTENSION SET
MDR report key: 3941458
·
Received April 16, 2014
Report
- Report Number
- 9616066-2014-00321
- Event Type
- Malfunction
- Date Received
- April 16, 2014
- Report Date
- March 18, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K051499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS IT WAS DISCARDED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS NOT IDENTIFIED.
Description of Event or Problem · 1
CUSTOMER REPORTED LEAKING FROM THE FILTER AREA DURING A TPN INFUSION. EVENT OCCURRED IN THE ICU. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232256 | MAXPLUS EXTENSION SET | FPA | CAREFUSION CORPORATION | MX9166 | 12095884 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NON-CAREFUSION PRIMARY SET: MFR/MODEL/LOT UNK |