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

Model Number CARDIOHELP-I

Device Problems Increase in Pressure (1491); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2022

Event Type  Injury  

Event Description

The vigilance area of medical devices of the spanish agency of medicines and medical devices has been informed through (b)(6) registry about an incident involving the product ¿cardiohelp system¿, manufactured by getinge and distributed by , occurred on (b)(6) 2022, in the hospital (b)(6).The reference number assigned to this incident is (b)(4).It was reported that after 7 days of therapy a membrane dysfunction is suspected due to sudden elevation of transmembrane pressures.There were no hemolysis or oxygenation deficits.Therefore the oxygenator and pump were exchanged.The consequence was: a need for surgical intervention to avoid injury or permanent disability.Complaint id#: (b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id (b)(4).

Manufacturer Narrative

The vigilance area of medical devices of the spanish agency of medicines and medical devices has been informed through (b)(4) about an incident involving the product ¿cardiohelp system¿, manufactured by getinge and distributed by , occurred on (b)(6) 2022, in the (b)(6) hospital.It was reported that after 7 days of therapy a membrane dysfunction is suspected due to sudden elevation of transmembrane pressures.There were no hemolysis or oxygenation deficits.Therefore the oxygenator and pump were exchanged.The consequence was: a need for surgical intervention to avoid injury or permanent disability.The affected hls set will be investigated in complaint# (b)(4) (mfg report number 8010762-2023-00361).On 2023-10-17 the information was received that the getinge service and sales unit (ssu) could not get any answers from the customer.The event happened a long time ago.According to the ssu this complaint is related to the (b)(4) program that generates many incident notices that most of the time are not related to the device.The exact root cause remains unknown, as the product was not available for investigation and no further information of the event was received.However, according to the risk file of the cardiohelp device the following root causes can lead to the reported failure: defective/disturbed (emi) pressure sensor.Defective pressure sensor.Connection of non-compatible sensors.Wrong plugged external pressure sensor or disconnection (mix up).Too high/low atmospheric 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 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.The review of the non-conformities has been performed on (b)(6) 2023 for the period of first nc 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.Based on the available information the reported event "membrane dysfunction due to sudden elevation of transmembrane pressures" could not be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from (b)(6) 2022 till (b)(6) 2023).The customer will be informed about the results by the getinge sales and service unit.The occurrence rate related to the reported event 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.No information was received about which device serial of ch was used in this event.

• 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: 17406687
• MDR Text Key: 319923075
• Report Number: 3008355164-2023-00029
• 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: Distributor
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2023
• Distributor Facility Aware Date: 10/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2023
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening