MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-03 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) 201-90401 manufactured by Thoratec Switzerland Gmbh.
[177934139]
The cause of this event is not conclusive and is also reported in cmag motor under mfr #2916596-2020-00544. No further information was provided. A supplemental report will be submitted when the manufacturer? S investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[177934140]
It was reported that the patient was in the intensive care unit (icu). The pressure cable from the centrimag (cmag) console was accidentally disconnected by the clinical team. The cmag console subsequently alarmed showing s3 alarm. The primary cmag console was switched with a backup console.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00379 |
| MDR Report Key | 9660589 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-12 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BOB FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528204 |
| Manufacturer G1 | THORATEC SWITZERLAND GMBH |
| Manufacturer Street | TECHNOPARKSTRASSE 1 |
| Manufacturer City | ZURICH CH-8005 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-8005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-02-03 |
| Model Number | 201-90401 |
| Lot Number | 6224746 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC SWITZERLAND GMBH |
| Manufacturer Address | TECHNOPARKSTRASSE 1 ZURICH CH-8005 SZ CH-8005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |