MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90010

Device Problems Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 03/16/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the nurse heard change in breathing of the patient and upon investigation found the patient to be profusely bleeding.An arrest call was put out.The ventricular assist device (vad) line was disconnected around the abdominal area and was reconnected at the time, yet difficult to assess the exact location of disconnection.There was a possible disconnection at the cannula or at the changeout connector.The patient passed away the following day.Regulatory reference report mfr # 3003306248-2023-05081; 3003306248-2023-05082.

Event Description

It was additionally reported that the disconnection site was believed to be the left ventricular assist device drainage line side, near where it exits the patients skin.It was possible that either the tubing disconnected from the cannula or tubing disconnected from the changeout connector.The connections were not secured with tie bands.Attempts were made to resuscitate the patient using other mechanical support.At the time, the issue was not thought to be an equipment failure.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted images confirmed blood loss that was reportedly due to a tubing disconnection.Images were submitted of the bi-vad circuit from immediately after the incident.Each of the bi-vad pumps had their inflow and outflow sections of tubing clamped with hemostats.The left ventricular assist device (lvad) had a section of air in the tubing along approximately 5 inches on the inlet side of the pump, consistent with the reported blood loss.Drops of bright-red blood were also noted on the floor and on the side of the hospital bed.The centrimag blood pump, lot # l07756-la6, was not returned for evaluation as it was discarded.Review of the device history record (dhr) for the centrimag (cm) blood pump (dhr cm pump l07756-la6) revealed no deviations from manufacturing or quality assurance specifications.The ous (outside the united states) centrimag ventricular assist device (vad) instructions for use (ifu), (rev.A), is currently available.Intended use/indications: the centrimag system is intended for use for up to 30 days to support one or both sides of the heart.The ifu contains the following warnings and cautions: ifu warning #17: frequent patient and device monitoring is recommended.Ifu warning #28: all blood tubing connections should be banded.Also insure that tubing is connected past the second barb on all connectors for added protection against high fluid pressures.Ifu warning #33: check to verify that all connections are secure before use.Ifu caution # 14: always have a spare centrimag vad, centrimag back-up console and spare equipment readily available for change.The ous (outside of the united states) 2nd generation centrimag system operating manual (doc.# pl-0280, rev.L) sections ¿7.3.3 response to system alarms or alerts¿ and ¿11.1 appendix i ¿console alarms and alerts¿ contain lists of console alarms and alerts as well as appropriate operator response to these events.Section 9 ¿emergency/troubleshooting¿ provides instructions on replacing components during certain circumstances.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS
• 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: 17845530
• MDR Text Key: 324615975
• Report Number: 3003306248-2023-05080
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-90010
• Device Lot Number: L07756-LA6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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
• Patient Outcome(s): Death