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); Protective Measures Problem (3015)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

It was reported that hls cable stopped working during use.Afterwards information received that the affected component is the venous probe.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

New information received that the cardiohelp was exchanged during treatment and there was no issue with the hls cable.The failure was that the venous probe is not reading sat/hct.Complaint id: (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair on 2022-11-17/18.The venous probe and the venous probe cable were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The device history record (dhr) of the cardiohelp (material: 701072780, serial:(b)(6)) was reviewed on 2022-11-21.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.A follow up will submitted when additional information become available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that hls cable stopped working.Afterwards the information was received that the affected component is the venous probe and the hls cable does not have any malfunction.The measurements of the venous probe were not being displayed on the cardiohelp (value hct, hb).The failure occurred during use and the cardiohelp was exchanged.A getinge field service technician (fst) was sent for investigation and repair on (b)(6) 2022.The venous probe was replaced to solve the issue and the venous probe cable was replaced as a precaution.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the risk file v24 of the cardiohelp following root causes can lead to the reported failure: defective / disturbed (emi) sensor measurement.Wrong measurement values caused by sediments in the disposable.Response time is too long.Light influences.Blood light spectrum differences.Total fail/defect of venous probe (e.G.Because of mechanical damage).Breaking of optical fiber.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6) was reviewed on 2022-11-21.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.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 instructions for use (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.Based on the results the reported corrected failure "measurements of the venous probe were not being displayed " 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: 15813809
• MDR Text Key: 307697524
• Report Number: 8010762-2022-00456
• 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: 01/05/2023

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: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/05/2022; 12/30/2022
• Supplement Dates FDA Received: 12/27/2022; 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1