FDA Adverse Event
Malfunction
Summary report: N
INFUSOR
MDR report key: 3110277
·
Received May 13, 2013
Report
- Report Number
- 1416980-2013-12224
- Event Type
- Malfunction
- Date Received
- May 13, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 18, 2013
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- MEB
- PMA / PMN Number
- K011317
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION 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 MULTI-RATE INFUSOR HAD EXPERIENCED REVERSE FLOW, DURING AN INFUSION. AFTER A NURSE CHECKED THE PORT NEEDLE AND FLUSHED THE INFUSOR WITH SALINE, IT WAS ATTACHED TO THE PATIENT. THE NURSE THEN NOTICED THAT BLOOD HAD BACKED UP FROM THE PORT TO THE INFUSOR, WHICH INDICATED A REVERSE FLOW. THIS EVENT OCCURRED DURING USE AND THERE WAS PATIENT INVOLVEMENT. HOWEVER, NO ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210244 | INFUSOR | PUMP, INFUSION, ELASTOMERIC | MEB | BAXTER HEALTHCARE - IRVINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |