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

Model Number CARDIOHELP.I

Device Problem Failure to Read Input Signal (1581)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

It was reported that the flow-/bubble sensor is defective.It was later added, that the flow values are fluctuating, when the sensor is touched.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 (b)(6) 2023 and could replicate the failure.The flow-/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.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 is defective.It was later added, that the flow values are fluctuating, when the sensor is touched.A getinge field service technician (fst) was sent for investigation and repair and could replicate the failure.The flow-/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The defective flow/bubble sensor was requested for further investigation, but it was not available.Therefore, the exact root cause remains unknown.The fst stated the failure was most probably due to a loose contact.Additionally, according to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: wrong flow / no flow information e.G.: - defective flow sensor - response time is too long 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.The review of the non-conformities has been performed on 2023-11-03 for the period of 2016-11-18 to 2023-11-02.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 2016-11-18.Based on the results the reported failure "flow/bubble sensor flow values fluctuating on touch" could be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device and the root cause "flow-/bubble sensor defective/response time too long" as a single event (timeframe from 2022-11-02 till 2023-11-02).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: 18137980
• MDR Text Key: 328124920
• Report Number: 8010762-2023-00571
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/15/2024

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: 11/02/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1