MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-18 for * manufactured by Terumo Medical Corporation.
[372102]
The nurse caring for the patient noticed a small drop of blood on the flowprobe. A short time later there was approximately 5cc of blood coming from a suspicious joint in the flowprobe and the perfusionist was alerted. The pump began to alarm "low flow". The site was clamped and the blood circulated through the bridge. The doctor was at the bedside, dopamine was started, and epinephrine was increased. Heart rate and bp remained satisfactory. Air accumulated next to the clamp and, with adjustment, was sent into the oxygenator. During this time a new flowprobe was inserted and the old one removed. This resulted in the patient being off the machine for 26 minutes. The patient did maintain good pressures and the epi was able to be weaned down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 606268 |
| MDR Report Key | 606268 |
| Date Received | 2005-05-18 |
| Date of Report | 2005-05-18 |
| Date of Event | 2005-05-10 |
| Report Date | 2005-05-18 |
| Date Reported to FDA | 2005-05-18 |
| Date Added to Maude | 2005-05-26 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | FLOWPROBE |
| Product Code | DPT |
| Date Received | 2005-05-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 596050 |
| Manufacturer | TERUMO MEDICAL CORPORATION |
| Manufacturer Address | 2101 COTTONTAIL LANE SOMERSET NJ 08873 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-18 |