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

Model Number 102952

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that the centrimag motor was making a loud rattling noise while centrimag extracorporeal membrane oxygenation (ecmo) support was turned on.There were no changes to hemolytic markers, centrimag or vital signs.The pump was switched to emergency backup equipment.Related manufacturer's reference number: (b)(4).

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported rattling noise could not be confirmed through this evaluation.A specific cause for the reported event could not be conclusively determined.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The centrimag blood pump was not returned for evaluation.The centrimag blood pump instructions for use (ifu) warns the user that frequent patient and device monitoring is recommended.If leaks or other anomalies are found, remove the blood pump and replace with a new, sterile blood pump.The ifu warns that back-up components must always be available and cautions the user to always have a spare centrimag pump, console, motor, and accessories available for use.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The centrimag blood pump instructions for use (ifu) are currently available.The ifu contains the following warnings and precautions: ifu warning #9: potential risk to the patient should be evaluated prior to changing a pump.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The section titled blood pump setup and operation warns the user that if leaks or other anomalies are found in the circuit, remove the blood pump and replace with a new, sterile blood pump.The ifu also contains a section titled emergency blood pump replacement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• 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
• 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: 17672542
• MDR Text Key: 322540554
• Report Number: 3003306248-2023-05069
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1