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

Model Number CARDIOHELP

Device Problem Communication or Transmission Problem (2896)

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

Event Date 08/11/2023

Event Type  malfunction  

Event Description

It was reported that during a patient transfer with a cardiohelp, the flowmeter (flow/bubble sensor was disconnected.After refitting there was a negative flow.The flowmeter (flow/bubble sensor) has been checked and was correctly positioned in the right direction.The customer changed the cardiohelp to a rotaflow console.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

A follow up will submitted when additonal information become available.

Manufacturer Narrative

It was reported that during a patient transfer with a cardiohelp, the flowmeter (flow/bubble sensor was disconnected.After refitting there was a negative flow.The flowmeter (flow/bubble sensor) has been checked and was correctly positioned in the right direction.The customer changed the cardiohelp to a rotaflow console.The failure occurred during treatment.A getinge field service technician (fst) was sent for investigation and repair.No failure could be replicated and no parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The fst determined that the problem was caused by the activated flow sensor.Due to this, the bubble sensor detected a bubble and stopped.Due to gravity, the sensor detected a negative flow.The log files of the reported cardiohelp device were reviewed and the reported failure description could be confirmed on the date of event.The error message "arterial bubble detected" due to activated intervention is logged on the date of event.The further error message: pump disposable error - stop could be linked to the exchange of the device and was therefore not further investigated.According to the instruction for use (ifu) 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.In the ifu chapter 6.4.4 "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.According to the ifu of the cardiohelp chapter 10 "cleaning and disinfection", the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore, in chapter 5.3 "connecting the sensors" it is stated that the sensors must be kept clean.The device was manufactured on 2022-10-14.The device history record (dhr) of the cardiohelp (material: 701048012, serial: (b)(6)) was reviewed on 2023-08-28.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "flowmeter (flow/bubble sensor) was disconnected.After refitting there was a negative flow." could be confirmed, but not a product related malfunction.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.

Event Description

Complaint id: (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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17593719
• MDR Text Key: 321630851
• Report Number: 8010762-2023-00406
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1