MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problem Failure to Read Input Signal (1581)

Patient Problem Death (1802)

Event Date 10/30/2020

Event Type  Death  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

The sensor on the arterial line failed, and it did not show the flow nor the bubbles, therefore the machine was switched, the patient died after a few days.Adverse event awareness date: (b)(6) 2020.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the flow/bubble sensor was not working.The device history record (dhr) of the cardiohelp (material: 701048012, serial: (b)(6)) for which a customer complaint was received, was reviewed on 2020-11-16.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.The cardiohelp was investigated by getinge life cycle engineering under lce4452 on 2021-03-01.It was determined that the flowdigiboard was defective.At the time of failure, the arterial bubble interventions were activated.Every bubble alarm causes the pump to stop.Due to the defective flowdigiboard the bubble alarm was permanently triggered and thus the bubble alarm cannot be reset.The root cause for the reported failure is a defective flowdigiboard.For further investigation a medical review was performed on (b)(6) 2021.After the pump stopped because of the failed flowdigiboard, the user tried to reset the arterial bubble detection three times in a time frame of 11 seconds.Then the user switched the arterial bubble sensor intervention off and the pump started to run.The total time of the pump stop was 54 seconds.During the event the user adjusted the ventilation from protective to more invasive ventilation.The patients¿ oxygen saturation declined from 87% to 74%, there was no change in the circulation and no other problem occurred.The patient died a view days after the event.According to the users statement the patients death was not a consequence of the pump stop.Based on the investigation results the reported failure could be confirmed but did not cause the death of patient.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: CARDIOHELP-I
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10822820
• MDR Text Key: 215870248
• Report Number: 8010762-2020-00384
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death