FDA Adverse Event
Malfunction
Summary report: N
IPUMP
MDR report key: 2140657
·
Received June 27, 2011
Report
- Report Number
- 6000001-2011-08940
- Event Type
- Malfunction
- Date Received
- June 27, 2011
- Date of Event
- May 23, 2011
- Report Date
- June 2, 2011
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K052973
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION:THE REPORTED CONDITION OF AN IPUMP WITH MISSING SEGMENTS ON THE DISPLAY WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS A DEFECTIVE DISPLAY. THE DISPLAY WAS REPLACED TO FIX THE REPORTED CONDITION.
Additional Manufacturer Narrative · 1
(B)(4).THE SAMPLE WAS RETURNED FOR EVALUATION HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED AN IPUMP WITH A CONDITION OF 'HAS A DEFECTIVE DISPLAY'. THIS CONDITION OCCURRED DURING PROGRAMMING/SETUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO PATIENT INVOLVEMENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IPUMP | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |