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 2017-12-22 for THORATEC CENTRIMAG VAD KIT, OUS 201-90001 manufactured by Thoratec Switzerland Gmbh.
[95721691]
The event occurred at clinica (b)(6). The centrimag components were not returned for evaluation. The drainage cannula was forwarded to the original equipment manufacturer (oem). 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
[95721692]
The patient was placed on extracorporeal circulatory support on (b)(6) 2017. It was reported that the venous drainage cannula from another manufacturer had a cloudy white color, suspicious of a white clot. The patient? S lactate dehydrogenase level increased and an echocardiogram showed images compatible with thrombus. Prior to and during the surgery on (b)(6) 2017 to change the cannula, the patient was doing well. 24 hours post-operatively, the patient presented with massive bleeding. It was? Reviewed surgically? But the bleeding could not be controlled. Reportedly, the patient expired due to surgical problems after changing the cannula. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[112478624]
(b)(4). Additional information- age of device is 32 days. The report of a white opaque deposition within the venous drainage cannula was confirmed based on submitted photographs. Upon evaluation of the returned cannula, no thrombus or any other disposition were observed within the cannula. Therefore, specific characteristics of the material such as structure and texture could not be determined through this evaluation. The cannula was subsequently forwarded to the manufacturer, who provided their evaluation of the returned device. The manufacturer issued a letter dated 27mar2018 summarizing the investigation performed on the cannula, the evaluation of the cannula did not reveal any device-related issues. The letter further indicated that per their ifu, their cannulae are only intended for cannula drainage from the superior and inferior vena cava during extracorporeal circulation for a duration of less than 6 hours. However, the ifu included in the centrimag vad kit, which is specific to the disposable centrimag blood pump, has an indication for use of up to 30 days. Per the letter from the manufacturer concluded the root cause for the reported event was likely due to use of the device outside of its intended timeframe. Root cause and corrective action for the labeling issue are being evaluated per internal capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2017-03329 |
| MDR Report Key | 7145026 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-22 |
| Date of Report | 2018-06-27 |
| Date of Event | 2017-12-06 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2017-12-22 |
| 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 | 6101 STONERIDGE DR. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528390 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE TECHNOPARKSTRASSE 1 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THORATEC CENTRIMAG VAD KIT, OUS |
| Generic Name | CENTRIMAG VAD KIT |
| Product Code | OJE |
| Date Received | 2017-12-22 |
| Catalog Number | 201-90001 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC SWITZERLAND GMBH |
| Manufacturer Address | TECHNOPARKSTRASSE 1 ZURICH, CH-8005 SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention | 2017-12-22 |