FDA Adverse Event
Malfunction
Summary report: N
CE INFUSOR LV10, 12 PACK
MDR report key: 1771080
·
Received July 27, 2010
Report
- Report Number
- 6000001-2010-01980
- Event Type
- Malfunction
- Date Received
- July 27, 2010
- Date of Event
- June 22, 2010
- Report Date
- July 12, 2010
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- MEB
- PMA / PMN Number
- K071222
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV10 WAS LEAKING BEFORE USE. THE DEVICE WAS FILLED WITH A SOLUTION OF 13.5 GRAMS TAZOCIN 230 MILLILITERS NORMAL SALINE WHEN THE LEAK WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CE INFUSOR LV10, 12 PACK | PUMP, INFUSION, ELASTOMERIC | MEB | BAXTER HEALTHCARE - IRVINE | 09J026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |