MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-01-19 for TRILLIUM BIO-PROBE, ADULT DP-38T 1160270-545 manufactured by Medtronic Perfusion Systems.
[444361]
Probe would not function approximately one hour after the start of the case. The product was replaced during bypass with no pt complication reported. The user indicated the device was discarded by the facility following case completion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2006-00007 |
| MDR Report Key | 667148 |
| Report Source | 05,07 |
| Date Received | 2006-01-19 |
| Date of Report | 2006-01-04 |
| Date of Event | 2006-01-04 |
| Date Facility Aware | 2006-01-04 |
| Report Date | 2006-01-04 |
| Date Reported to Mfgr | 2006-01-04 |
| Date Mfgr Received | 2006-01-04 |
| Date Added to Maude | 2006-01-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WEIK |
| Manufacturer Street | 8299 CENTRAL AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635146694 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRILLIUM BIO-PROBE, ADULT |
| Generic Name | FLOW PROBE |
| Product Code | DPT |
| Date Received | 2006-01-19 |
| Model Number | DP-38T |
| Catalog Number | 1160270-545 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 656512 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Baseline Brand Name | TRILLIUM BIO-PROBE, ADULT |
| Baseline Generic Name | FLOW PROBE |
| Baseline Model No | DP-38T |
| Baseline Device Family | BIO-PROBES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K830858 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-19 |