MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-26 for KIMBERLY CLARK EASI-LAV 1534 * manufactured by Kimberly Clark.
[318508]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029600 |
| MDR Report Key | 487626 |
| Date Received | 2003-08-26 |
| Date of Report | 2003-08-05 |
| Date of Event | 2003-07-17 |
| Date Added to Maude | 2003-10-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIMBERLY CLARK EASI-LAV |
| Generic Name | ADULT GASTRIC LAVAGE KIT |
| Product Code | KDH |
| Date Received | 2003-08-26 |
| Model Number | 1534 |
| Catalog Number | * |
| Lot Number | 197624 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 476507 |
| Manufacturer | KIMBERLY CLARK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-26 |