MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2019-12-30 for CATHETERS & CANNULAE 10016#AVALON ELITE 16F, 14CM 701063533 manufactured by Maquet Cardiopulmonary Gmbh.
[182546616]
The customer reported: a (b)(6) kg patient who went on vv ecls through the neck with a 16f avalon. It was in the correct position and working well. After 5 days, the patient was proned and the cannula migrated. It was half as effective, but the patient was going to come off ecls the next day, so the decision was to leave it rather than coming off and re-positioning. The patient failed to wean the next day and left on. During the night, the cannula punctured the right atrium and caused a tamponade. The patient was opened and re-cannulated centrally to va ecls. After 2 days, the patient was weaned and remains stable. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2019-00400 |
| MDR Report Key | 9529195 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2019-12-30 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2019-12-30 |
| 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 | CATHETERS & CANNULAE |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2019-12-30 |
| Model Number | 10016#AVALON ELITE 16F, 14CM |
| Catalog Number | 701063533 |
| Lot Number | 246799 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2019-12-30 |