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

Model Number CARDIOHELP-I

Device Problem Pumping Stopped (1503)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information become available.

Event Description

It was reported, that the event occurred during priming, but the cardiohelp was exchanged.Further it was reported, that the customer stopped and switched the pump as a lot of blood had spilled on the unit.No further information were provided.No harm to any person has been reported.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair.The fst found blood underneath fan mechanism on device along with ports.Thus, the sensor panel was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow up will submitted when additional information become available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

Based on the investigation of the device and re-evaluation of the complaint, this event is deemend as non reportable.Please see our following investigation for your information: it was reported, that the event occurred during priming.Blood was spilled on the unit, the customer decided to stop using the machine and switched the pump.No information regarding a malfunction of the cardiohelp was received.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair.The fst found blood underneath fan mechanism on device along with ports.The device was sent to inhouse repair.Due to blood contamination, the fan sensor panel was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.(refer to service order report 44636778 and service order report 44657874).Therefore, as stated by getinge field service technician the fan/sensor panel failed due to contamination with blood.Further, according to the risk file v24 of the cardiohelp device (dms# 2021972) the following root causes can lead to the reported failure: the user accidentally spills liquids (e.G.Cleaning agents, infusion solution, etc.) over the device.The liquids enter the device.In the instruction for use (ifu, chapter: "10.1.1 surface cleaning") the following is written: "to remove soiling or residual blood, clean the device and cables after each use." moreover, in the ifu (instruction for use, "2.3.1 inter-hospital patient transportation") the following is written: "carry the cardiohelp protection cover with you.In rain or splash water, affix the protection cover to the cardiohelp-i.It increases the degree of protection according to iec 60529 from ipx1 to ip33.Without the protection cover, rain or splash water may enter the housing.If the cardiohelp-i has been exposed to rain or splash water without the protection cover or water may have penetrated the housing, take the cardiohelp-i out of service after use, and have the cardiohelp-i checked by authorized service personnel.The device was manufactured on 2022-09-12.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6) was reviewed on 2024-01-17.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "a lot of blood had spilled on the unit" could be confirmed, but the issue is not related to a product malfunction.This complaint was found in the database of customer complaints for cardiohelp as a single event (timeframe from 2022 (b)(6) till 2023 (b)(6).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: 18281402
• MDR Text Key: 329889371
• Report Number: 8010762-2023-00606
• 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: 02/29/2024

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-I
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 02/16/2024
• Supplement Dates FDA Received: 01/25/2024; 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1