MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for AVALON ELITE BI-CAVAL LUMEN CATHETER, 31 FR 10031#AVALON ELITE 31F, 31CM 701063538 manufactured by Maquet Cardiopulmonary Gmbh.
[180708048]
The sample was discarded by the hospital.
Patient Sequence No: 1, Text Type: N, H10
[180708049]
It was reported that the customer had a patient with respiratory failure, they initially put in a 27 french (lot# 218747) on (b)(6) 2019 and it kept torquing so they changed it out to a 31 french (lot# 205257) on (b)(6) 2019, but it was extremely positional? They had to put layers of 4x4s under the cannula to maintain flow at a steady level. Original cannula was placed using xray and replacement cannula was placed using fluoro. On 2020-02-06 further information was received: the patient expired. Ct of the head showed anoxic brain injury. The patient? S official cause of death from autopsy was bronchial pneumonia? Lungs were described as completely fibrotic. Oxygen sats were low unless the cannula was manipulated. The cannula needed manipulation every few hours to maintain oxygen sats above 80. If the circuit tubing connected to the cannula was not repositioned the oxygen sats would decrease and the pao2 was low as well. With manipulation oxygen sats would increase to the 90? S and pao2 would increase as well. On xray and ultrasound the cannula was always in the correct position. On the final autopsy result the cannula was determined to be in correct placement. Note: this complaint (31 fr cannula) is related to complaint # (b)(4)(27 fr cannula). Both complaints concern the same patient but different products. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008355164-2020-00009 |
| MDR Report Key | 9749562 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-12-02 |
| Date Facility Aware | 2020-02-03 |
| Report Date | 2020-02-25 |
| Date Reported to FDA | 2020-02-25 |
| Date Reported to Mfgr | 2020-02-25 |
| Date Added to Maude | 2020-02-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVALON ELITE BI-CAVAL LUMEN CATHETER, 31 FR |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-02-25 |
| 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 | 2020-02-25 |