MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for HLM TUBING SET W/BIOLINE COATING BE-HLS 7050 #HLS SET ADVANCED 7.0 manufactured by Maquet Cardiopulmonary Gmbh.
[180707755]
A follow up medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[180707756]
Patient who transfers us by influenza a for venous ecmo, venovenous is installed with hls cardiohelp device functioning correctly the first two days and the third need of very high gas flows 12l / min for a blood flow of 3. 2l of blood flow, and hypercapnia it is decided to change the device for another hls cardiohelp happening to the same as the first. An incident with cannulas (decannulation) is used to replace it with a third party. This last cardiohelp is established on (b)(6), on (b)(6) we return to a hypercapnia situation with maximum gas flows. When i talk about pco2 figures i mean the membrane output. New information received on 2020-02-24: patient died on (b)(6) 2020. Complaint id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008355164-2020-00007 |
| MDR Report Key | 9749531 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-09 |
| Date Facility Aware | 2020-02-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HLM TUBING SET W/BIOLINE COATING |
| Generic Name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Product Code | DTZ |
| Date Received | 2020-02-25 |
| Model Number | BE-HLS 7050 #HLS SET ADVANCED 7.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 |