MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,foreign,health profe report with the FDA on 2015-02-26 for SINGLE ROLLER PUMP MODULE MCP0.0703309 manufactured by Maquet Cardiopulmonary Ag.
[5457747]
It was reported that one of the rpm 20's ran at full speed momentarily. This happened just after the case while emptying the vent lines. No reported patient effect. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12996623]
A supplemental medwatch will be submitted when additional information becomes available. (b)(4). Both products are components of the hl20 integrated perfusion system cleared under 51(k) k943803.
Patient Sequence No: 1, Text Type: N, H10
[68539165]
Field safety technician has been investigated and found failure reported. He added the grounding and no further instances since then. Thus the failure could be confirmed. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00118 |
| MDR Report Key | 4562023 |
| Report Source | 00,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-02-26 |
| Date of Report | 2015-01-20 |
| Date of Event | 2015-01-19 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2015-03-31 |
| 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 Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE ROLLER PUMP MODULE |
| Product Code | DPW |
| Date Received | 2015-02-26 |
| Model Number | MCP0.0703309 |
| Catalog Number | MCP0.0703309 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-26 |