FDA Adverse Event
Malfunction
Summary report: N
INFUSOR
MDR report key: 2841532
·
Received November 21, 2012
Report
- Report Number
- 1416980-2012-05696
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 1, 2012
- Report Date
- October 31, 2012
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- MEB
- PMA / PMN Number
- K062457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PROBLEM IS NOT CONFIRMED AND THE CAUSE CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 1
(B)(4). PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BAXTER (B)(6) RECEIVED A REPORT OF AN INFUSOR THAT DID NOT FLOW DURING PATIENT THERAPY. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THIS CONDITION INTERRUPTED THERAPY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSOR | PUMP, INFUSION, ELASTOMERIC | MEB | BAXTER HEALTHCARE - IRVINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |