FDA Adverse Event
Malfunction
Summary report: N
MAXGUARD ADMINISTRATION SET
MDR report key: 2082583
·
Received April 27, 2011
Report
- Report Number
- 3005748548-2011-00004
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- February 21, 2011
- Report Date
- March 3, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K051499
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED IN SECTION A AND B. THE SET HAS BEEN REC'D; HOWEVER, THE INVESTIGATION IS NOT COMPLETE. A F/U REPORT WILL BE SUBMITTED ONCE THE EVAL HAS BEEN DONE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT A LEAK OCCURRED AT THE FILTER SITE WHILE INFUSING REMICADE AT AN ARTHRITIS CENTER. NO HARM REPORTED TO PT OR CLINICIAN. NO ADD'L PT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXGUARD ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | MFS137 | 11277333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |