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

Model Number CARDIOHELP-I

Device Problems Device Sensing Problem (2917); No Flow (2991)

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

Event Date 10/08/2022

Event Type  malfunction  

Event Description

The customer reported that no flow could be established to prime the system.The event occurred during priming and another cardiohelp was used instead.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation on 2022-10-14.The failure could not be replicated.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The review of the non-conformities has been performed on 2022-12-02 for the period of 2020-07-09 to 2022-10-11.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2020-07-09.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the flow bubble sensor did not display flow values.The failure occurred during the priming.No harm to any person was reported.A getinge field service technician (fst) was sent for investigation and repair on 2022-10-14.The failure could not be replicated.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log file review was performed by getinge life cycle engineering on 2022-12-07.No abnormalities were identified in regards to the flow bubble sensor.The zero flow mode (backflow prevention) was not active.No exact root cause could be identified, because the failure could not be replicated.However, according to the risk file v24 of the cardiohelp device following root causes can lead to the reported failure: - influence due to other ultrasonic devices (e.G.Flow sensor) - bubble sensor not plugged but recognized - environmental influences (atmospheric pressure, temperature, humidity, emi, over voltage) - sensors are disturbed by external electric or magnetic field (emi) or ultrasonic system the disposables involved in this event could be ruled out as a possible root cause, because the customer attached the oxygenator to another cardiohelp, which then solved the issue.According to the instruction for use chapter 5.3.1 connecting the combined flow/bubble sensor the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus a defective flow/bubble sensor should be detected prior to use, during priming.In addition as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.The review of the non-conformities has been performed on (b)(6)2022 for the period of (b)(6) 2020 to (b)(6) 2022.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2020-07-09.Based on the results the reported failure "flow bubble sensor did not display flow values" could not be confirmed.The customer will be informed about the results by the getinge sales and service unit.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.

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15938479
• MDR Text Key: 306688295
• Report Number: 8010762-2022-00491
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1