MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-06 for LIFEPORT KIDNEY TRANSPORTER SYSTEM LKT200 manufactured by Organ Recovery Systems, Inc..
| Report Number | 3004068499-2020-00003 |
| MDR Report Key | 9678334 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-03-18 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ROXANNE GEARY |
| Manufacturer Street | 1 PIERCE PLACE SUITE 475W |
| Manufacturer City | ITASCA IL 60143 |
| Manufacturer Country | US |
| Manufacturer Postal | 60143 |
| Manufacturer Phone | 8478242600 |
| Manufacturer G1 | ORGAN RECOVERY SYSTEMS, INC. |
| Manufacturer Street | 1 PIERCE PLACE SUITE 475W |
| Manufacturer City | ITASCA IL 60143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60143 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3004068499-1/30/20-001R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEPORT KIDNEY TRANSPORTER SYSTEM |
| Generic Name | PERFUSION CIRCUIT |
| Product Code | KDN |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-02-05 |
| Model Number | LKT200 |
| Catalog Number | LKT200 |
| Lot Number | 119944 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS, INC. |
| Manufacturer Address | 1 PIERCE PLACE SUITE 475W ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |