MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-02-21 for LIFECARE 1050 CONTROLLER 01904 manufactured by Random Corp..
[41256]
Overdelivery reported. The pump was set to infuse d5ns at 125ml/hr. A new iv container was started 2:40am. At 4:50am, a nurse noted that less than 200ml remained in the 1000ml container. The expected delivery amount was approx 275ml. No device alarms sounded. The iv fluid rate was decreased to a keep open rate and the pt was observed closely. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[7760785]
The reported problem could not be duplicated. There have been not death or serious injury reports for code 102 (overdelivery) for the last 12 months for this list number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1580411-1997-00001 |
| MDR Report Key | 71382 |
| Report Source | 05,06 |
| Date Received | 1997-02-21 |
| Date of Report | 1997-01-24 |
| Date of Event | 1997-01-23 |
| Date Facility Aware | 1997-01-23 |
| Report Date | 1997-01-24 |
| Date Mfgr Received | 1997-01-24 |
| Device Manufacturer Date | 1987-03-01 |
| Date Added to Maude | 1997-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFECARE 1050 CONTROLLER |
| Generic Name | INFUSION PUMP |
| Product Code | LDR |
| Date Received | 1997-02-21 |
| Model Number | NA |
| Catalog Number | 01904 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 71277 |
| Manufacturer | RANDOM CORP. |
| Manufacturer Address | 551 NORTHLAND BLVD CINCINNATI OH 45240 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-21 |