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)

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

Event Date 08/11/2023

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 that the integrated pressure reading was fluctuating when the connector was moved or wiggled.The failure occurred during treatment and system restore.Complaint id # (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) performed a system restore on 2023-11-03.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

It was reported that the integrated pressure reading were fluctuating when the connector was moved or wiggled.The failure was initially reported during a system restore.It was later confirmed by the customer that the failure also occurred during treatment.The treatment was continued without exchanging the cardiohelp.No harm to any person has been reported.The device caused the complaint and was not able to work as per factory¿s specifications.A getinge field service technician (fst) performed a system restore on (b)(6) 2023.The fst confirmed that there was no corrosion or damage to the connector 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 reviewed and the pressure issues could not be confirmed on date of event, (b)(6) 2023, as there are no pressure values present in the logfiles.A similar failure was investigated by getinge life-cycle-engineering.The most probable root cause that the wetting of the socket plan from the hls connector affected the measurement voltages for the arterial pressure.This lead to the unstable value changes of the pressure.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 must 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.The review of the non-conformities has been performed on (b)(6) 2023 for the period of (b)(6) 2017 to (b)(6) 2023.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 (b)(6) 2017.Based on the results the reported failure "integrated pressure fluctuating" 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.

Event Description

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: 18137658
• MDR Text Key: 328131349
• Report Number: 8010762-2023-00569
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1