FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ 3.13 SINGLE C
MDR report key: 4071827
·
Received August 12, 2014
Report
- Report Number
- 9615050-2014-04772
- Event Type
- Malfunction
- Date Received
- August 12, 2014
- Date of Event
- July 21, 2014
- Report Date
- July 22, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED DURING REVIEW OF THE DEVICE HISTORY AT THE USER FACILITY A S321 MALFUNCTION ALARM CODE WAS NOTED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FROM THE CENTRAL PROCESSING DEPT WITH AN UNSIGNED NOTE THAT STATED "ALARMING MALFUNCTION". NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 478989 | SYMBIQ 3.13 SINGLE C | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |