MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07,company repres report with the FDA on 2015-02-03 for MAQUET HL20 TWIN PUMP NI manufactured by Maquet Cardiopulmonary Ag.
[5332832]
It was reported that during surgery, the cardioplegia slave pump (on the twin roller pump) stopped with the error message safety-s. No reported patient effect. No additional information was provided. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12802081]
The safety-s error refers to a failure regarding a recurring deviation between the measured and the set value of 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 pump 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 instruction is the user manual. A supplemental medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[57743626]
Unable to confirm the failure due to not getting information from the customer. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
[57743627]
Additional information: reference: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2015-00053 |
| MDR Report Key | 4491482 |
| Report Source | 00,01,05,06,07,COMPANY REPRES |
| Date Received | 2015-02-03 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-09-25 |
| Date Mfgr Received | 2014-09-05 |
| Date Added to Maude | 2015-03-09 |
| 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 | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET HL20 TWIN PUMP |
| Product Code | DPW |
| Date Received | 2015-02-03 |
| Model Number | NI |
| Catalog Number | NI |
| 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 | 2015-02-03 |