MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-12 for CARMEDA AFFINITY? PEDIATRIC ARTERIAL BLOOD FILTER S4014 manufactured by Perfusion Systems.
[141771916]
Event date; month and year valid only. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[141771917]
Medtronic received information via a solicitor that a patient is alleged to have suffered oxygen deprivation, seizures, hypoxic ischemic injury and brain damage. A list of devices which included a medtronic arterial filter, blood pump, tubing and cannulae as well as heart lung machine, oxygenator, autotransfusion device and reservoirs from non-medtronic companies. Information was provided that there were flow issues due to clotting and the arterial filter was bypassed. A new circuit was primed and put on standby but was not used. There has not been any communication from the hospital of any malfunction to a medtronic device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2019-00014 |
| MDR Report Key | 8509373 |
| Report Source | OTHER |
| Date Received | 2019-04-12 |
| Date of Report | 2019-07-23 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2019-03-15 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2019-04-12 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR |
| 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 | CARMEDA AFFINITY? PEDIATRIC ARTERIAL BLOOD FILTER |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2019-04-12 |
| Model Number | S4014 |
| Catalog Number | S4014 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-12 |