FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ DUAL CHANNEL
MDR report key: 3894437
·
Received April 25, 2014
Report
- Report Number
- 9615050-2014-02991
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- January 1, 2014
- Report Date
- March 28, 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
- MO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED DEVICE ALARMED WITH A S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMED DEPT FOR AN UNSPECIFIED REASON. NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, A S321 MALFUNCTION ALARM CODE WAS NOTED. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252334 | SYMBIQ DUAL CHANNEL | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |