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); Pressure Problem (3012); Temperature Problem (3022)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported both pressures, arterial temperature (t-art), and venous temperature (t-ven) were unstable and drifting.The failures occurred during maintenance.No harm to any person has been reported.Complaint id # (b)(4).

Event Description

Complaint id # (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair between 2023-12-06 and 2023-12-18.The sensor panel 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

A fst was sent for investigation and repair between 2023 (b)(6).The fst could not confirm the pressure reading issue.The temperature failure could be confirmed.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 reviewed there were no error message regarding any pressure failures could be confirmed.However the temperature failures, "tart sensor disconnected" and "tven sensor disconnected" could be confirmed on the date of event.The life cycle engineering (lce) investigated the sensor panel.According to the investigation, the issue could be reproduced for the reading of t-ven upon application of freeze spray or by shaking the connector or pushing its leads in different directions.This behavior indicates connection issues within the connector or its circuity to the pcb.According to the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.4, chapter 6.1 preparation and installation and quadrox-ir small adult / adult, chapter 7.2 priming the system) the pressure sensors have to be calibrated and checked before priming.Furthermore, the cardiohelp has a flow/bubble sensor and a venous probe 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.Following the ifu of the cardiohelp, chapter 5.3 "connection the sensors", it is stated to ensure that the connected sensors are not defective and to not use, if there is a visible damage.In addition, (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 the ifu chapter 5.3 "connecting the sensors" it is stated that the sensors must be kept clean.Moreover, in case of a failing arterial/venous temperature sensor an external sensor can be connected (ifu, chapter 5.3.3 "connecting external temperature sensors").Further, chapter 9 "messages", if the measured values are above high limit or below low limit of the set limits and if the sensor is defective the system generates a visual and acoustical alarm.Also, (chapter 6 ¿during the application¿) the cardiohelp should only be operated with activated temperature sensors and to ensure that the warning and alarm limits, as well as the interventions, are suitable for the patient and current situation.An external temperature sensor can be used.The venous probe does not influence the blood flow of the device.The venous probe is for monitoring the blood gas values (hemoglobin (hb), hematocrit (hct), oxygen saturation (svo2) and venous temperature).In the ifu, chapter 2.2.5 "monitoring and sensors" of the cardiohelp system it is stated that these values must be regularly checked by the user via a blood gas analysis by a laboratory.Furthermore, in the ifu is stated that prior to a therapeutic measure based on the parameters displayed a laboratory blood gas analysis must be checked.The cardiohelp generates an acoustic and visible alarm in case of a failure of the venous probe.Additionally, in the ifu chapter 5.1 "application overview for disposables", is stated that if the disposable was changed during operation the venous probe could be re-initialized again.Continuing, in the ifu chapter 5.3 "connection the sensors" is stated to ensure that the connected sensors are not defective and to not use, if there is a visible damage.The venous probe is operated with a supply voltage of 9v.Voltages below 10 v can be perceived under certain conditions (e.G.Wet skin), but there is no risk for harm due to an electrical shock.Lastly, to monitor the patient temperature the venous temperature is measured by the venous probe.Further in case of a failing arterial/venous temperature sensor an external sensor can be connected (refer to ifu , chapter 5.3.3 "connecting external temperature sensors").According to the ifu of the cardiohelp chapter 9 "messages", if the measured values are above high limit or below low limit of the set limits and if the sensor is defective the system generates a visual and acoustical alarm.The device was manufactured on 2022-02-22.The device history record (dhr) of the cardiohelp was reviewed on 2023 (b)(6).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 "arterial temperature (t-art), and venous temperature (t-ven) were unstable and drifting" could be confirmed, however "both pressures were unstable and drifting" could not be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2022-11-20 to 2023-11-20).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: 18181575
• MDR Text Key: 328632306
• Report Number: 8010762-2023-00582
• 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,Followup,Followup
• Report Date: 05/10/2024

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: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/19/2023; 05/03/2024
• Supplement Dates FDA Received: 01/11/2024; 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1