FDA Adverse Event
Malfunction
Summary report: N
INFUSOR
MDR report key: 4180416
·
Received October 17, 2014
Report
- Report Number
- 1416980-2014-36208
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Date of Event
- February 4, 2014
- Report Date
- September 23, 2014
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE WAS MANUFACTURED OCTOBER 5, 2012 TO OCTOBER 6, 2012. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LARGE VOLUME INFUSOR HAD NO FLOW DURING INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663226 | INFUSOR | PUMP, INFUSION, ELASTOMERIC | MEB | BAXTER HEALTHCARE - IRVINE | 12K005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |