MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-04 for AFFINITY OXY NT 511 95212 manufactured by Perfusion Systems.
[182297863]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182297864]
Medtronic received information that during use, the customer reported an issue with the nt oxygenator. Perfusionist set up and primed the oxygenator with no issues. Cpb was initiated and noticed the oxygen levels were good. He checked the blender and oxygen connections and all were good. He then connected oxygen tank to the circuit in case the hospital source was defective. He turned the oxygen way up and got some improvement. After a few minutes, the oxygen levels were back down. He informed the surgeon that he was going to change out the oxygenator. Upon doing this when he removed the oxygenator from the cardiotomy/venous reservoir (cvr) and a huge piece of the gas cap broke off the oxygenator and remained connected to the cvr. The customer suspects there was a crack in the gas cap of the oxygenator and it was leaking and that is why the oxygen levels were low. When he removed it, the oxygenator broke along the crack. The product was replaced. There was no adverse effect to the patient. All of this occurred after the cross clamp was placed and cardioplegia was given. The perfusionist said it took about 6 to 7 mins to change out and re-initiate cpb. Anesthesia ventilated and the surgeon feels all is ok. The patient exhibited normal post op characteristics. No patient effects. Patient has been discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2020-00013 |
| MDR Report Key | 9787269 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-10-24 |
| Date Added to Maude | 2020-03-04 |
| 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 | 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 | AFFINITY OXY NT 511 |
| Generic Name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Product Code | DTZ |
| Date Received | 2020-03-04 |
| Model Number | 95212 |
| Catalog Number | 95212 |
| Lot Number | 13313981 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2020-03-04 |