MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-15 for BREEZE LIFECARE 175 IV PUMP * manufactured by Abbott Laboratories.
[15260037]
Pump display indicated that the desired intravenous amount was infused at the correct rate. When in fact no intravenous fluid was delivered. It was determined the tubing set up by the rn was correct pump malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013557 |
| MDR Report Key | 163662 |
| Date Received | 1998-04-15 |
| Date of Report | 1998-04-08 |
| Date of Event | 1998-04-08 |
| Date Added to Maude | 1998-04-23 |
| 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 |
| 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 | BREEZE LIFECARE 175 IV PUMP |
| Generic Name | IV PUMP |
| Product Code | LDR |
| Date Received | 1998-04-15 |
| Model Number | BREEZE LIFECARE 175 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 159310 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | ONE ABBOTT PARK RD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-15 |