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

Model Number CARDIOHELP-I

Device Problems Communication or Transmission Problem (2896); Infusion or Flow Problem (2964)

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

Event Date 04/08/2024

Event Type  malfunction  

Event Description

It was reported that while the flow/bubble sensor is clamped off, it will not hold zero during calibration.The failure occurred during maintenance.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

It was reported that while the system is clamped off, the flow/bubble sensor it will not hold zero during calibration.The failure occurred during maintenance.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation on 2024-04-08.The fst confirmed that there were no contamination or visible damage on the flow/bubble sensor.The flow/bubble 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 reviewed and ¿art.Bubble sensor defective¿ could be confirmed on the date of event.A similar failure was investigated by the life cycle engineering.According to the investigation in specific pairing of the flow/bubble sensor with the sensor panel, fluctuations with values can be observed.In order to investigate this behavior the supplier em-tec initiated a capa.- 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 "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 "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 device was manufactured on 2022-04-29.The device history record (dhr) of the cardiohelp was reviewed on 2024-04-16.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 "flow/bubble sensor it will not hold zero during calibration" could be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2023-04-08 till 2024-04-08).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: 19181689
• MDR Text Key: 341051072
• Report Number: 8010762-2024-00233
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• 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: 701072780
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1