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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that the customer had problems with the flow meter (flow/bubble sensor) of the cardiohelp.The cardiohelp was exchanged during treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair on 2023-06-01.The sensor panel was replaced and the cardiohelp.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow up will submitted when additional information become available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the customer had problems with the flow meter (flow/bubble sensor) of the cardiohelp.The cardiohelp was exchanged during treatment.A getinge field service technician (fst) was sent for investigation and repair on 2023-06-01.The sensor panel was replaced and the cardiohelp.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp were reviewed and no malfunction could be confirmed on the date of event.A similar failure was investigated by getinge life cycle engineering (lce) and as most probable root cause an unreliable plug connection on the digiflow mini-board led to the error.Moreover, according to the risk analyses file of the cardiohelp, version 24, the most probable root cause is a defective connection between the sensormbridge board and the digiflow board caused by an electro static discharge (esd).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 instructions for use (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 2020-02-10.The review of the non-conformities has been performed on 2023-06-05 for the period of 2020-02-10 to 2031-05-31.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.Based on the results the reported failure "customer had problems with the flow meter (flow/bubble sensor) of the cardiohelp" could 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: 17068827
• MDR Text Key: 316594846
• Report Number: 8010762-2023-00259
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/30/2023

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-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1