MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-26 for MAQUET HL-20 TWIN PUMP MCP00703279 70102.8694 manufactured by Maquet Cardiopulmoary Ag.
[5228607]
On (b)(6) 2011, at (b)(6), the customer reported that after the twin pump module tpm 20-330, twin roller pump (article number: 70102. 8694, serial number: (b)(4)) attached to the hl20 is configured as cardioplegia (left pump) and cardioplegia-slave (right pump) that over time the configuration then returns to the default free mode. In addition, the cardioplegia-slave has displayed an "rpm-diff" error message. The hospital reported this to the maquet service representative on (b)(6) 2011. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12597973]
(b)(4). Maquet cardiopulmonary ag provides product failure investigation, analysis, and resolution for the device described in this report. The service technician checked both pump head speeds and verified pump head speeds. There is no documentation that any repair was performed. The device was not returned to the manufacturer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00526 |
| MDR Report Key | 4280441 |
| Report Source | 05,06 |
| Date Received | 2014-11-26 |
| Date of Report | 2011-10-29 |
| Date of Event | 2011-10-21 |
| Date Facility Aware | 2011-10-29 |
| Report Date | 2011-10-29 |
| Date Reported to Mfgr | 2011-10-29 |
| Date Mfgr Received | 2011-10-29 |
| Device Manufacturer Date | 2005-04-30 |
| 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 CARDIOPULMOARY 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 | MCP00703279 |
| Catalog Number | 70102.8694 |
| 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 |