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 2020-03-11 for HLM TUBING SET W/BIOLINE COATING BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0 70105.2794 manufactured by Maquet Cardiopulmonary Gmbh.
[183170897]
Customer has an hls set that developed a high pressure for unknown reason and had to swap out the set for another hls set. Complaint id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2020-00098 |
| MDR Report Key | 9820860 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-11 |
| 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 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 | HLM TUBING SET W/BIOLINE COATING |
| Generic Name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Product Code | DTZ |
| Date Received | 2020-03-11 |
| Model Number | BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0 |
| Catalog Number | 70105.2794 |
| 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 | 2020-03-11 |