MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-07-28 for HL-20 TWIN PUMP 70102.8692 MCP00703277 manufactured by Maquet Cardiopulmonary Ag.
[6037215]
On (b)(6) 2013 at (b)(6), it was reported through the support system complaint number 1071 that the control board on the tpm 20-330 twin roller pump module serial number (b)(4) was defective after the unit was upgraded to software version 2. 5. The ssu reported that the unit displayed various errors. Upon request for further information, the ssu said that it was not possible to operate the device in a program mode (only free mode was available). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14217659]
Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). The device was evaluated by a ssu technician and the control board was found to be defective and was replaced. The control board was returned to mcp in germany for investigation. During the investigation, the device displayed a 'no comm' error. The cause of the error was determined to be a damaged dc/dc converter. The damage was caused by a mechanical force which lifted two of the 8 pins of the dc/dc converter. It is likely that the damage occurred during the software update where the control board was pulled out of the tpm housing and the eeprom is changed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00878 |
| MDR Report Key | 4944781 |
| Report Source | 01,05,06 |
| Date Received | 2015-07-28 |
| Date of Report | 2013-07-31 |
| Date of Event | 2013-07-31 |
| Date Facility Aware | 2013-07-31 |
| Report Date | 2013-07-31 |
| Date Reported to Mfgr | 2013-07-31 |
| Date Mfgr Received | 2013-07-31 |
| 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 | 70102.8692 |
| Catalog Number | MCP00703277 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |