MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problems Pumping Stopped (1503); Electrical Power Problem (2925); Infusion or Flow Problem (2964)

Patient Problem Anxiety (2328)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The site reported the centrimag began to alarm while supporting a patient.The flows and rpms were noted to be 0.The system was re-started and flows were increased.The site was able to get the patient back to his original settings.During the event, the patient complained of being short of breath.A decision was made to exchange the system to the backup.The centrimag system stopped again as the account was grabbing the backup system.The system was exchanged and flows returned to normal without the patient becoming entirely hemodynamically compromised.The patient's peripheral capillary oxygen saturation dropped to the 70s.The patient was extremely anxious and treated with ativan.The patient returned to baseline.No further information was reported.

Manufacturer Narrative

Mfr name, city & state, report source: correction.

Manufacturer Narrative

Section b5, h4: additional information.Manufacturer's investigation conclusion: the centrimag 1st gen primary console (sn (b)(6)) and motor (sn (b)(6)), used during the reported event of multiple system stops during patient support, were not returned for analysis.Multiple attempts for product requests were made but did not receive a response.As a result, the root cause of the reported event could not be conclusively determined during the investigation.Per reported information, the system was exchanged a back-up system and the patient returned to baseline after the exchange.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number: 2916596-2019-05943.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 9482115
• MDR Text Key: 174470724
• Report Number: 2916596-2019-05942
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 03/20/2020
• Supplement Dates FDA Received: 12/23/2019; 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 71