MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE

Model Number 102954

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2018-00848. This report is being submitted as additional information. The patient age, weight, gender were requested but were not provided. Approximate age of device- 6 years, 11 months (calculated from date of manufacture). Manufacturer's investigation conclusion: the reported event was confirmed through the evaluation of the returned centrimag console; however, a root cause could not be determined. The returned centrimag console was checked for internal and external damage upon receipt and no damage was observed. The console history maintenance card was inspected and it was noted that no maintenance was performed since 11-mar-2011. The console was charged overnight in order to perform battery maintenance test. Upon removing ac power during the battery maintenance test, the console shut down after a minute of run time, confirming the reported event. The old battery was replaced. A full functional checkout was performed and all tests passed. A warning label was installed and instructions were included. The console will be returned to the customer site. The centimag primary console operating manual shows how to identify the power source in use and the charge remaining in the internal battery. It also outlines internal rechargeable battery pack replacement and maintenance (rechargeable battery pack must be replaced every 2 years and battery maintenance should be performed once every 6 months) and outlines the operator responses to all primary console alarms and alerts. No further information was provided. The manufacturer is closing the file on this event.

Event Description

The patient was being supported with an extracorporeal circulatory support pump. It was reported that the centrimag (cmag) primary console¿s internal battery depleted when the patient was being transported by emergency medical services (ems). It is unknown if the patient was adversely impacted by the event. Additional information was requested but not provided.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8656636
• MDR Text Key: 146634471
• Report Number: 2916596-2019-02598
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage