FDA Adverse Event
Malfunction
Summary report: N
CE INTERMATE LV 100, 24 PACK,50126
MDR report key: 1821833
·
Received August 31, 2010
Report
- Report Number
- 6000001-2010-02893
- Event Type
- Malfunction
- Date Received
- August 31, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 12, 2010
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- FRN
- PMA / PMN Number
- K910425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 TWO INTERMATE LV 100 DEVICES WERE LEAKING BEFORE USE. THIS IS REPORT NUMBER 2 OF 2. THE DEVICES WERE FILLED WITH 90 MILLIGRAMS PAMIDRONATE IN 250 MILLILITERS OF 0.9% NACL WHEN THE LEAKS WERE OBSERVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CE INTERMATE LV 100, 24 PACK,50126 | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - IRVINE | 10B004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |