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

Model Number CARDIOHELP-I

Device Problem Increase in Pressure (1491)

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

Event Date 06/28/2022

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

The customer reported that arterial pressure sensor failed on an hls set during a procedure.All other pressure readings from the integrated pressure/temperature sensor cable were displayed, however the tart read as defective.See attached photo.Provider was able to get the arterial temperature to read again by applying slight tension to the integrated pressure sensor cable.Set remains in use on a patient.No harm to patient.No patient information provided.Effected cardiohelp sn listed below as well as disposable in question.Onetrack complaint id: (b)(4).

Event Description

Onetrack complaint id: (b)(4).

Manufacturer Narrative

It was reported that internal pressure and arterial temperature readings failed during treatment.The customer changed to a new connection cable for internal sensors which functioned appropriately.Since this fixed the failure, the customer did not request any further service of the device.It was confirmed by the fst that no visible damage could be found on the cable.Another disposable connection cable with the same failure was investigated by getinge life cycle engineering on 2021-08-30.The root cause for the reported malfunction could be traced back to a missing electrical connection within the cable.The root cause for the missing connection is a broken wire within the cable, which most likely originated from external force.Furthermore, according to the risk analysis v24 following root causes can also linked to the reported failure: a mechanical damage e.G.Due to too high forces during connection/ disconnection of the cable.Broken fiber inside the cable.According to the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.3, 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.According to the instruction for use of the cardiohelp (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 device was manufactured on 2017-06-19.The review of the non-conformities has been performed on 2022-06-10 for the period of 2017-05-19 to 2022-06-08.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 to have contributed to the reported failure.Based on the results the reported failure "internal pressure and arterial temperature readings failed" 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: 14875198
• MDR Text Key: 301947155
• Report Number: 8010762-2022-00256
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose