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

Model Number CARDIOHELP

Device Problem Pumping Problem (3016)

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

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information becomes available.A getinge technician will investigate the unit in question.

Event Description

It was reported that provider noticed a strange sound coming from the pump.Information received that customer was able to transition to a new pump.No harm to any person has been reported.Complaintnumber: (b)(4).

Manufacturer Narrative

It was reported that the provider noticed a strange sound coming from the pump.The event occurred during treatment.The cardiohelp was exchanged.No harm to any person has been reported.It was confirmed by getinge service and sales unit that the customer cannot provide the information which cardiohelp was concerned.Thus, no service in relation to the reported failure was requested by the customer.However, it was confirmed by getinge service and sales unit that all cardiohelp pumps in their fleet were serviced at the time of the incident and tested again by service team after the incident to ensure no future issues.It was presumed by the customer (not confirmed) that the disposable needed to be changed out and clotting was causing the noise (not confirmed).No information about the disposable was available, except of the lot number, #3000191316.According to manufacturer data base 13 cardiohelp devices were sold to the customer.9 of the 13 cardiohelp devices are older than 2 years and therefore a review of the non-conformities were performed.4 of the 13 cardiohelp devices are younger than 2 years and therefore a device history review was performed.For 9 out of the 13 cardiohelp (manufacturing date 2015-2018) a review of the non-conformities has been performed on 2022-11-18 for the period of 2015-09-08 to 2022-05-19.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.For 4 out of 13 cardiohelp (manufacturing date 2021) the device history record (dhr) was reviewed on 2022-11-18.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.A device history record review for the hls set was performend on 2022-11-18 for the affected beq-015703112 #shls module advanced adul with packaging lot#3000191316.According to the final test results, the hls module with lot# 3000191311 passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results no exact root cause could be identified.However, according to the risk file v24 of the cardiohelp (dms# 2021972) the following root causes can also linked to the reported failure: - electromagnetic disturbances generated by other medical devices in proximity to the device, except high frequency surgical equipment or defibrillators.-electromagnetic disturbances generated by high-frequency surgical equipment or defibrillators in proximity to the device.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instructions for use (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 g-670 version 03 · us) "chapter 4.2 safety instructions for the extracorporeal circulation": no anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.Use anticoagulants; e.G.Heparin or argatroban.Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).Ensure that the act value does not fall below the value which is appropriate for the application.Based on the investigation results, no malfunction could be confirmed.This complaint was found in the database of customer complaints as a single event (2021-05-19 till 2022-05-19).The customer will be informed about the results by the getinge sales and service unit.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.Note: when relevant information become available, the complaint will be re-opened and further investigation steps will be initiated.

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: 14539405
• MDR Text Key: 294420110
• Report Number: 8010762-2022-00193
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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
• Device Catalogue Number: N/I
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 05/30/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose