FDA Adverse Event
Malfunction
Summary report: N
KIMBERLY CLARK EASI-LAV
MDR report key: 487626
·
Received August 26, 2003
Report
- Report Number
- MW1029600
- Event Type
- Malfunction
- Date Received
- August 26, 2003
- Date of Event
- July 17, 2003
- Report Date
- August 5, 2003
- Manufacturer
- KIMBERLY CLARK
- Product Code
- KDH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
UPON ATTEMPTING TO LAVAGE PT, THE RED SIDE OF THE PUMP FAILED AND WAS DRAINING AIR FROM THE WASTE BAG AS OPPOSED TO STOMACH CONTENTS FROM THE PT. AFTER 2 ROUNDS OF WATER INSTALLATION, THE BLUE SIDE BEGAN TO FAIL AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KIMBERLY CLARK EASI-LAV | ADULT GASTRIC LAVAGE KIT | KDH | KIMBERLY CLARK | 1534 | 197624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |