MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30100

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

The motor associated with this event is being reported under mfr # 2916596-2020-00219.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 was implanted with centrimag and a sudden "flow below minimum" alarm occurred without any manipulation of the patient or system.At the same time was noted on the rpm display.The clinical team noted that there was no blood flow through the pump and the pump had stopped.The primary console, motor, and flow probe were immediately changed and blood flow was restored.The patient had adequate oxygenation and was hemodynamically stable during the event.

Manufacturer Narrative

Section h3: additional information section h4: additional information manufacturer investigation conclusion: the report of a "flow below minimum" alarm and a pump stop event (speed display showing "----" rpm) could not be confirmed nor reproduced during testing of the returned centrimag primary console (sn (b)(6)).The returned primary console was evaluated and tested at the european distribution center (edc).Visual inspection did not reveal any issues.The returned system was powered on and booted up as intended.The reported event could not be reproduced during the evaluation.The returned console supported the system without any issues and passed low speed burn-in, high speed burn-in, as well as full functional testing.Safety testing was performed and the unit was charged for a minimum of 12 hours without any issues.The returned primary console operated as intended during the investigation.As a result, the root cause of the reported event could not be conclusively determined nor correlated to a primary console related issue.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.

• Brand Name: PRIM CONS 1ST GEN, STANDALONE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9678356
• MDR Text Key: 178097525
• Report Number: 2916596-2020-00705
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 201-30100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization