MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-03-18 for MAQUET VARIO TWIN, HL 20, 4-PUMPS NI 70104.3262 manufactured by Maquet Cardiopulmonary Ag.
[5658462]
It was reported that the during self test single roller pump moving high speed and showing errors safety s and run away. The safety-s error refers to a failure regarding a recurring deviation between the measured and set value of the pump speed of at least 10%. Example: the pump speed is set with 1000 rounds per minutes (rpm) and the actual speed is measured on the pump head with greater than 1100 rpm. In order to protect the pt from excessive pump speed, an automatic pump stop is generated together with the safety-s error. In order to restart the pump, the user has to follow the instructions in the user manual. No known consequences to the pt. No further info have been provided to the mfr. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13102433]
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device, maquet cardiopulmonary (b)(4). Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report. Field safety technician checked the unit and found the problem on the motor control board, which needs to be replaced. Field safety technician checked with another pump parts and tested and found that motor control board was defective. Part has to be replaced against warranty.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00262 |
| MDR Report Key | 4620303 |
| Report Source | 05,06,07 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-02-23 |
| Date of Event | 2015-02-23 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-05-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET VARIO TWIN, HL 20, 4-PUMPS |
| Generic Name | MAQUET VARIO TWIN, HL 20, 4-PUMPS |
| Product Code | DPW |
| Date Received | 2015-03-18 |
| Model Number | NI |
| Catalog Number | 70104.3262 |
| Lot Number | NA |
| 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 | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-18 |