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

Model Number 102956

Device Problems No Display/Image (1183); Nonstandard Device (1420); Electrical Power Problem (2925); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2019

Event Type  Injury  

Manufacturer Narrative

The console failure to display information and not detect flow was reported under mfr # 2916596-2019-00833.The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date and unique identifier (udi) are unknown.The device did not return for analysis.Similar reports has been investigated and the reported difficulty was the result of a design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott will perform a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The investigation will be submitted as a follow-up once it is complete.

Event Description

The patient was being supported with a ventricular assist device for acute support.It was reported the console screen "went black" while supporting the patient; the monitor displayed information but perfusionist was unable to turn console screen back on.No flow and s3 alarms were showing on centrimag monitor although rpm was showing, and console was not detecting flow.One bedside specialist checked for flow in cannulas and forward flow was noted.Rpms were reduced to switch the patient to the backup system, causing flow to decrease.Clinician immediately dropped flows to 1l by reducing rpm, and then specialist clamped tubing and changed out consoles to backup.The switch to backup system was performed with no issues.Flow was returned to circuit.It was reported the patient's vitals stabilized and pre and post-oxygenator gas was drawn.An arterial blood gas (abg) sample from arterial line was sent to lab for evaluation of oxygenation status.No additional information was provided.

Manufacturer Narrative

Analysis conclusion.The report of drops in pump speed and flow blanking was confirmed through the analysis of a data log file retrieved from the returned 2nd gen primary console (serial number (b)(6).Per the log file, the console was supporting a pump at a speed of ~4600rpm and a flow of ~4.5lpm for over 711 hours.At approximately (b)(6) 2019 the log file captured an active system alert:s3 alarm as a result of an active sf_ifd_shutdown_detected fault.After this alarm occurred, pump speed dropped to ~3200rpm and the flow reading dropped to 0lpm.Attempts to adjust pump speed to 4800rpm were unsuccessful and the flow reading remained blank until the console was powered down.The centrimag motor used at the time of the reported event was not returned for analysis.Multiple requests for product return and additional information did not receive a response.As a result, the root cause of the reported event could not be conclusively determined.However, reports of similar events have been documented and corrective action (capa) has been initiated to investigate and address the issue.Reports of similar events will continue to be tracked and monitored.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8946207
• MDR Text Key: 156889401
• Report Number: 2916596-2019-04218
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 96