MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 102954

Device Problems Pumping Stopped (1503); Battery Problem (2885)

Patient Problems Loss of consciousness (2418); No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided.Approximate age of device ¿ 8 years 11 months 26 days.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient's battery was below minimum and the pump stopped.The site switched to the backup console.Additional information was requested but not provided.

Manufacturer Narrative

Description of event or problem: additional information mfr name, city & stat, mfr site, report source: correction.Device manufacture date: additional information.Manufacturer's investigation conclusion: the reported event of the battery being below minimum, and the pump stopping was not confirmed.The centrimag 1st generation primary console was not returned for analysis.Provided information indicated that the site switched to the backup console.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The site communicated that the pump stopped while on c-mags and was changed over to the backup console.The patient was transferred to vanderbilt for transplant and later died due to multi organ failure.

Event Description

The patient was being ambulated in the unit and the backup battery failed during the excursion and the patient had to be switched over to the backup console.The patient was assisted to the chair with loss of consciousness when the console stopped and once connected to the backup console the patient regained consciousness.The console was removed from service and an internal incident report was filed.No further information was provided.

Manufacturer Narrative

Sections event and patient codes: additional information.Section manufacturer name and location, manufacturer site,and report source: corrected data.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8801745
• MDR Text Key: 151409602
• Report Number: 2916596-2019-03298
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 10/25/2019; 11/18/2019
• Supplement Dates FDA Received: 11/14/2019; 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 75