FDA Adverse Event
Malfunction
Summary report: N
CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK
MDR report key: 1953128
·
Received January 7, 2011
Report
- Report Number
- 6000001-2011-00131
- Event Type
- Malfunction
- Date Received
- January 7, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 22, 2010
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- FRN
- PMA / PMN Number
- K910425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. 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 FRANCE THAT THE RESERVOIR OF AN INTERMATE LV 250 DEVICE RUPTURED DURING PATIENT USE. THE DEVICE WAS DELIVERING MERONEM IN 250 MILLILITERS NACL TO THE PATIENT WHEN THE RESERVOIR RUPTURED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - IRVINE | 10H111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NACL| MERONEM |