FDA Adverse Event
Malfunction
Summary report: N
U0707 TINA SINGLE PUMP NIBPLCD
MDR report key: 1844385
·
Received September 24, 2010
Report
- Report Number
- 1423500-2010-03720
- Event Type
- Malfunction
- Date Received
- September 24, 2010
- Date of Event
- August 30, 2010
- Report Date
- August 30, 2010
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- KDI
- PMA / PMN Number
- K970446
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ACTUAL DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF BROKEN WHEEL WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. APPROPRIATE CORRECTIVE ACTION WAS TAKEN TO RESOLVE THE ISSUE BY PERFORMING ALL THE NECESSARY TESTS, CALIBRATIONS AND REPAIRS. THE REAR WHEEL WAS REPLACED ON THE DEVICE TO FIX THE REPORTED CONDITION. THE DEVICE HAS PASSED ALL TESTING. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BAXTER (B)(4) RECEIVED A REPORT FROM THE CUSTOMER STATING THAT THE DEVICE HAD A BROKEN WHEEL. THE BAXTER FIELD SERVICE REPRESENTATIVE WENT ONSITE TO REPAIR THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U0707 TINA SINGLE PUMP NIBPLCD | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |