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

Model Number CARDIOHELP-I

Device Problem Pumping Stopped (1503)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is pending.The sales and service unit informed that the oxygenator was scrapped by the customer.

Event Description

Complaint number: (b)(4).During patient treatment it was reported that the cardiohelp showed the alarm ¿pump disposable error¿ and the blood flow stopped.As a medical intervention the emergency drive was used to the blood flow.The hls set and unit were both changed out will no complications.After event the black sensor cable for the disposable was noted to be frayed.

Manufacturer Narrative

It was reported that the cardiohelp showed the alarm ¿pump disposable error¿ and the blood flow stopped.The device caused the complaint and was not able to work as per factory specifications.The hls set was scrapped by the customer.A getinge service technician was on site and investigated the unit on 2021-02-10.According to the service report id#(b)(4) the pump disposable error could not be reproduced.The device was able to work as per factory specifications.The log files of the cardiohelp were analyzed by getinge technical support on 2021-03-25 and the reported failure ¿pump disposable error¿ could be confirmed within the logs.According to ifu of the hls set, chapter 5.3.1 "safety instructions for the oxygenator" the most probable root cause of the pump disposable error could be caused by the disposable when disconnecting from the cardiohelp during the pump is running.The error can also be caused when the pump is not set to zero before connecting the disposable.The hls-set is not available for investigation, however with the provided lot number of the set the production records of the affected hls set (dms# 3080183, 3067811, 3073378) and all related components were reviewed on 2021-03-25.Following tests are performed as a 100 % inspection: - function test; - final product test; according to the final test results, all oxygenators passed the tests as per specifications.Production related influences can be excluded.The device history record does not show any abnormality or issue that is related or can have led to the customer complaint.The occurrence rate was calculated for the reported issue 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.

Event Description

Complaint number: (b)(4).

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11326915
• MDR Text Key: 232200143
• Report Number: 8010762-2021-00117
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• 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: 70107.2780
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention