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

Model Number 102953

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Cardiac Arrest (1762); Sepsis (2067); Ventricular Fibrillation (2130); Drug Resistant Bacterial Infection (4553); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

It was reported that the patient was on a protek duo cannula and a centrimag pump with another manufacturer's oxygenator.A heparin bolus was provided; about 2 hours into the run the surgeon heard a clicking motor noise from the centrimag pump.The site reseated the pump head twice with no success.The entire circuit was changed out with new centrimag pump but using the same motor and console.This resolved the noise.

Event Description

The patient presented to an outside hospital with a witnessed cardiac arrest, ventricular-fibrillation, achieved delayed return of spontaneous circulation (rosc), but coded again in the emergency department.The patient was presented to the cardiac catheterization lab and a stent to right coronary artery (rca) and intra-aortic balloon pump was placed and removed 3 days later.The patient developed severe acute respiratory distress syndrome (ards) and methicillin-resistant staphylococcus aureus pneumonia (mrsa pna).The patient transferred hospitals for extracorporeal membrane oxygenation (ecmo) support.The patient became septic and was hyperkalemic.The patient developed depression and rapidly progressed to asystole.The patient expired on (b)(6) 2021 and the death was not considered device related.

Manufacturer Narrative

Patient death will be reported under manufacturer report number 2916596-2021-05430 as death occurred on a separate blood pump.Manufacturer's investigation conclusion: the report of a clicking noise from the blood pump could not be confirmed through this evaluation as no video/audio clips of the running centrimag system were submitted for review.A specific cause for the reported event could not be conclusively determined.The centrimag blood pump, lot number l0000007, was returned with tubing secured to the inlet and outlet ports with zip ties.Visual inspection of the pump¿s inlet and outlet ports of the pump, as well as the pump housing showed no evidence of cracking or other damage.Examination of the pump's blood-contacting surfaces revealed no evidence of depositions or thrombus formations.Visual inspection of the blood pump revealed no evidence of abrasion or other damage to the impeller blades or remainder of the rotor and showed no evidence of abnormal scratches on the pump housing or rotor well.There was no evidence of separation or slippage between the rotor magnet and rotor body.Following cleaning, microscopic inspection of the blood pump revealed no anomalies.The blood pump was functionally tested on a mock circulatory loop with a test motor and equipment.The blood pump functioned as intended in accordance with manufacturing specification; no clicking noise was heard.The centrimag blood pump instructions for use (ifu) (rev.09) lists the adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: 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 on the centrimag vad, remove the blood pump and replace with a new, sterile blood pump.The ifu also contains a section titled emergency blood pump replacement.Review of the device history record (dhr) for the centrimag blood pump, lot #l0000007 revealed no deviations from manufacturing or quality assurance specifications.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
• MDR Report Key: 11474854
• MDR Text Key: 239823185
• Report Number: 3003306248-2021-01065
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L0000007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 37 YR
• Patient Weight: 135