MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-02-24 for AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 31FR 10031#AVALON ELITE 31F, 31CM 701063538 manufactured by Maquet Cardiopulmonary Gmbh.
[180615344]
The sample is not available for return.
Patient Sequence No: 1, Text Type: N, H10
[180615345]
This patient is a (b)(6) year old male with influenza a, the customer put him on support with a 31 french cannula. This cannula was placed using xray and ultrasound. The customer reported issues with the cannula being positional despite perfect placement. Further information received on 2020-02-06: "the (b)(6) year old male? S cannula is now flowing without issues. There was a tee performed yesterday which showed the cannula is in perfect placement. All the extra supports i had placed on the cannula and circuit were removed the patient? S head was turned side to side and the cannula did not move. Not sure why there were issues the first two days but now? All resolved.? The customer stated on (b)(6) 2020:? Our patient expired early this morning and i was not able to retrieve the cannula.? (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2020-00085 |
| MDR Report Key | 9746275 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-24 |
| 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 Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 4972229321 |
| Manufacturer G1 | NURSEL BOELENS |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 31FR |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-02-24 |
| Model Number | 10031#AVALON ELITE 31F, 31CM |
| Catalog Number | 701063538 |
| Lot Number | 205257 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY GMBH |
| Manufacturer Address | NEUE ROTTENBURGER STRASSE 37 HECHINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-24 |