MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-07-28 for ARROW HEMOSONIC 100 SYSTEM HSM-00100 manufactured by Arrow International, Inc..
[181900]
It was reported that the device was in use to monitor a pt with an abdominal aortic aneurysm using only total cardiac output from the monitor. The physician did not consider the other factors such as systemic vascular resistance, changes in blood flow, stroke volume, etc. Based on only the cardiac output readings, he gave the pt fluids. As a result of the user error, the pt developed pulmonary edema. The pt recovered and there were no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219856-2000-00184 |
| MDR Report Key | 287417 |
| Report Source | 05 |
| Date Received | 2000-07-28 |
| Date of Report | 2000-07-25 |
| Date Mfgr Received | 2000-07-14 |
| Date Added to Maude | 2000-08-01 |
| 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 | 0 |
| Manufacturer Street | 2400 BERNVILLE RD |
| Manufacturer City | READING PA 19605 |
| Manufacturer Country | US |
| Manufacturer Postal | 19605 |
| Manufacturer Phone | 6104783159 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW HEMOSONIC 100 SYSTEM |
| Generic Name | HEMOSONIC MONITORING SYSTEM |
| Product Code | DPW |
| Date Received | 2000-07-28 |
| Model Number | NA |
| Catalog Number | HSM-00100 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 278119 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Manufacturer Address | 2400 BERNVILLE RD READING PA 19605 US |
| Baseline Brand Name | ARROW HEMOSONIC 100 SYSTEM |
| Baseline Generic Name | HEMOSONIC MONITORING SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | HSM-00100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-07-28 |