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

Model Number CARDIOHELP-I

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

It was initially reported that the sensor panel needs replacement.Subsequently, it was reported that there was a malfunction with the flow/bubble sensor.The failure occurred during priming.A getinge field service technician (fst) performed repair on (b)(6).2023.The fst could confirm there was no damage on the flow/bubble sensor, flow/bubble sensor cable, and the sensor panel.The sensor panel was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were requested but was not provided.A similar failure was investigated by getinge life cycle engineering (lce) germany.In order to investigate this behavior the supplier, em-tec, initiated a capa.In specific pairing of the flow/bubble sensor with the sensor panel, fluctuations can be observed.- the inspection of the complete stock did not reveal any other anomalies.The 100% inspection focused on bent pins, insufficient solder joints, and the overall appearance of the boards.- submitted boards with the behavior occurring were studied in detail.In individual cases, the behavior described by the customer could be reproduced.- no deviations or nonconformities on boards or the sensors were apparent to explain the error behavior.All boards and sensors are technically flawless - the misconduct occurs only in individual cases.The cause is attributed to a chain of unfavorable factors.- the products do not show any visible technical defects.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 must 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.The review of the non-conformities has been performed on 2023-10-06 for the period of 2021-03-19 to 2023-10-03.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 2021-03-19.Based on the results the reported failure "flow/bubble sensor defective" 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.

Event Description

It was reported that the was a flow/bubble sensor malfunction.The failure occurred during priming.No harm to any person has been reported.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: 18246019
• MDR Text Key: 329480210
• Report Number: 8010762-2023-00598
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1