MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2014-11-26 for MAQUET HL-20 TWIN PUMP MCP00703277 MCP0.0703277 manufactured by Maquet Cardiopulmoary Ag.
[21329248]
On (b)(6) 2011, at (b)(6), an "arterial stop" error was received on twin pump module (tpm) en med c (article number: (b)(4)) while being used with hl20 5 pump console ((b)(4)) the arterial pump works properly (e. G. 100 rotations/min), however, the cardioplegia pump (in slave mode) turns a quarter of turn, then stops, then turns a half a turn, then stops, and so on. This problem was observed after the field service engineer performed a software update on the tpm from version 1. 4 to new software version 2. 5. A second mdr will be generated for this event since two twin pump module and console serial numbers are listed in the complaint. The second mdr # is 8010762-2014-01077. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21688380]
(b)(4). The field safety engineer (fse) performed the update mcv/011/0002/iu on 2 tpms. The fse updated software version 1. 4 to version 2. 5. Based upon communication with the service department, the version 2. 5 software was only for release 11 tpms, the tpms involved in this event were release 10. The fse was instructed to reinstall the old, version 1. 4 software on the tpms. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00504 |
| MDR Report Key | 4280410 |
| Report Source | 00,05,06,07 |
| Date Received | 2014-11-26 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-08-18 |
| Date Facility Aware | 2011-09-02 |
| Report Date | 2011-09-02 |
| Date Reported to Mfgr | 2011-09-02 |
| Date Mfgr Received | 2011-09-02 |
| Device Manufacturer Date | 2004-10-31 |
| Date Added to Maude | 2014-11-26 |
| 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 | TINA EVANCHO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097265 |
| Manufacturer G1 | MAQUET CARDIOPULMONARY AG |
| Manufacturer Street | 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 | MAQUET HL-20 TWIN PUMP |
| Generic Name | FLOWMETER, BLOOD, CARDIOVASCULAR |
| Product Code | DPW |
| Date Received | 2014-11-26 |
| Model Number | MCP00703277 |
| Catalog Number | MCP0.0703277 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMOARY AG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT, 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-26 |