MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2014-11-07 for MAQUET HL20 TWIN PUMP 70103.5075 manufactured by Maquet Cardiopulmonary Ag.
[5224646]
It was reported, that a twin roller pump stopped during cardioplegia. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12584167]
A maquet service technician found the pump had a manufacturing defect and will have the part replaced under warranty. Pump name: tpm 20-330 twin roller pump. Pump serial number: (b)(4). Pump part number of the hl 20: (b)(4). A supplemental medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-01228 |
| MDR Report Key | 4286022 |
| Report Source | 00,01,05,06 |
| Date Received | 2014-11-07 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-10-10 |
| Date Mfgr Received | 2014-10-10 |
| Date Added to Maude | 2014-12-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRABE 31 |
| Manufacturer City | RASTATT 76537 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76537 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET HL20 TWIN PUMP |
| Product Code | DPW |
| Date Received | 2014-11-07 |
| Catalog Number | 70103.5075 |
| 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 | RESTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-07 |