MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-07-28 for HL-20 TWIN PUMP 70103,5075 MCP00703323 manufactured by Maquet Cardiopulmonary Ag.
[6257880]
On (b)(6) 2013, at the (b)(6) hospital, (b)(6), it was reported that the tpm 20-330 twin roller pump module serial number (b)(4) displayed a head error on the right side pump when powered on. The device was removed from service and the customer was given a loaner unit. The non-conformity report indicates that the failure occurred prior to use on a patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14216856]
Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). The unit was investigated by a ssu service technician and the optical tachometer pcb was found to be defective and was replaced. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00975 |
| MDR Report Key | 4944755 |
| Report Source | 05,06 |
| Date Received | 2015-07-28 |
| Date of Report | 2013-12-19 |
| Date of Event | 2013-12-19 |
| Date Facility Aware | 2013-12-19 |
| Report Date | 2013-12-19 |
| Date Reported to Mfgr | 2013-12-19 |
| Date Mfgr Received | 2013-12-19 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2015-07-28 |
| 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 | HL-20 TWIN PUMP |
| Generic Name | FLOWMETER, BLOOD, CARDIOVASCULAR |
| Product Code | DPW |
| Date Received | 2015-07-28 |
| Model Number | 70103,5075 |
| Catalog Number | MCP00703323 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT, 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-28 |