MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HCU 30

Device Problem Insufficient Heating (1287)

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

Event Date 05/03/2022

Event Type  malfunction  

Event Description

It was reported that the hcu 30 patient side was not warming properly.The device showed the error message ¿1004 - main heater temp.Sensor error¿.If the error ¿1004¿ occurs during patient treatment, potential heating malfunction results.The failure occurred prior to use, during selftest of the device.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hcu 30 patient side was not warming properly.The device showed the error message ¿1004 - main heater temp.Sensor error¿.The failure occurred prior to use, during selftest of the device.No harm to any person has been reported.A getinge field service technician (fst) was on site for further investigation on 2022-05-03 and confirmed the reported failure.The fst reset the main side actuator and the 3-way valve.The device was observed over two hours and no error message was displayed.After repair the device was working as intended.With reference to the hcu 30 service manual (v07) for the failure "device does not heat up properly", different causes are possible, such as a defective 3-way-valve or a defective actuator.Furthermore, this failure may cause the error message ¿1004¿.After the fst reset the main side actuator and the 3-way-valve the issue was solved.No parts were replaced.Therefore, the most probable root cause for the reported failure were wrong settings of the 3-way-valve and actuator.The hcu 30 has been phased out since the end of 2010.The technical support, in-house repairs, as well as spare parts supplies have been discontinued in 2017.The review of the non-conformities has been performed on (b)(6) 2022 for the period of 2012-10-24 to 2022-05-03.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.The product in question was produced in 2012-10-24.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.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.

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, 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: 14405881
• MDR Text Key: 294054592
• Report Number: 8010762-2022-00167
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2022

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: HCU 30
• Device Catalogue Number: 701034642
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose