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

Model Number HCU 30

Device Problem Temperature Problem (3022)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the temperature of the cardioplegia side circuit of hcu30 stopped rising.The failure occured during patient treatment.The device was replaced with another heater cooler unit and the operation was continued.The getinge field service technician (fst) was on site for further investigation on 2021-06-25.The fst could not reproduce the failure.As a preventive character, the fst has replaced the actuators 24v ac / dc 50 / 60hz 2pcs ( material #(b)(4).Furthermore, the customer has been informed to check the device before clinical use.All function test passed.The device is back in clinical use.The device has received preventive maintenance in (b)(6) 2021.Based on the evaluated facts above, the reported failure "temperature stopped rising" could not be confirmed.However the failure can be linked to the following most possible root causes according to our risk management file (dms# (b)(4).Inadequate function because of: technical failure, software failure.The product in question was produced in 2006-07-03.The review of the non-conformities during the period of 2006-07-03 to 2021-06-25 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.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.

Event Description

Complaint #(b)(4).It was reported that the temperature of the cardioplegia side circuit of hcu30 stopped rising.The failure occured during patient treatment.The device was replaced with another heater cooler unit and the operation was continued.

• 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: 12148577
• MDR Text Key: 260945695
• Report Number: 8010762-2021-00384
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• 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: 939001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1