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

Model Number CARDIOHELP-I

Device Problems Decrease in Pressure (1490); Increase in Pressure (1491)

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

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a high pressure reading.The failure occurred during treatment.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

It was reported that there was a high pressure reading.The customer stated that the device was reading inaccurate pressures during treatment, once the circuit was clamped down.The pressure began to fluctuate from negative to positive.A getinge service technician (fst) was sent for investigation on 2022-06-09.The pressure values were within the tolerance range.Furthermore the fst confirmed that according to the logfiles no pump stop or error message occurred.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.Thus no exact root cause could be determined.However, according to the risk file v24 following root causes can lead to the reported failure: wrong pressure information due to: - wrong plugged external pressure or disconnection (mix up) - positive or negative pressure beyond specification (release of tubes) - to high/low atmospheric pressure in the instruction for use for the cardiohelp in chapter 2.2.4 "general precautionary measures during use" is stated to not bend or clamp the tube while the pump is running.Furthermore in the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.3, chapter 7.1 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.Further 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 2022-06-10 for the period of 2017-03-01 to 2022-06-09.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 2017-03-01.Based on the results the reported failure "high pressure reading" could not be reproduced and is not related to a device malfunction.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: 14653628
• MDR Text Key: 293706258
• Report Number: 8010762-2022-00218
• 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
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1