MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30105

Device Problems Infusion or Flow Problem (2964); No Apparent Adverse Event (3189)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that the nurse observed a low flow alarm while the patient was on centrimag (cmag) support in the intensive care unit.The nurse lowered the rpms to assess the situation.The nurse claimed that a "pump failure" error was observed when rpms were attempted to be raised back to the target flow.The patient was switched to the backup console, motor, and flow probe.Related manufacturer reference number for the centrimag primary console: mfr # 3003306248-2024-00005.Related manufacturer reference number for the centrimag motor: mfr # 3003306248-2024-00006.

Manufacturer Narrative

Section a1-a4: information was not provided.Pending follow up with the customer.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 centrimag flow probe (serial number (b)(6)) was returned and evaluated at the service depot following the reported event of the system having an atypical alarm active.The returned flow probe was tested with the returned centrimag console and motor as well as test equipment and the reported issues were not reproduced and no functional issues were identified.The log files reviewed from the returned console did not identify any potential issues with the flow probe specifically.The reported event could not be correlated to an issue with the flow probe.The device history records were reviewed for the centrimag flow probe (serial number: (b)(6)) and the flow probe was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual table 16 entitled ¿console alarms & alerts¿ addresses how to interpret and troubleshoot all system alarms including motor and flow alarms.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the perfusion team believed that the nurse increased flows on the backup centrimag and saw a pump not inserted alarm, but the nurse was adamant there was a technical issue with the pump.The low flows were caused due to a suction event, and it was noted that the patent's oxygen levels desaturated, however the pressure did not drop.There were no patient consequences due to the event.

• Brand Name: EM-TEC ADULT FLOW PROBE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18563557
• MDR Text Key: 333471883
• Report Number: 3003306248-2024-00007
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: 07640135140108
• 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: 05/22/2024

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: Health Professional
• Device Model Number: 201-30105
• Device Lot Number: 6693290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 59 KG