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

Model Number HCU 30

Device Problem Unexpected Shutdown (4019)

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

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

Further investigation is on-going.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint #(b)(4).It was reported that the hcu 30 had a burning smell and it turned off during clinical use.The machine was replaced during patient treatment.

Event Description

Complaint (b)(4).

Manufacturer Narrative

It was reported that the hcu 30 turned off during patient treatment with a burning smell.The device has been exchanged during patient treatment.No harm to any person has been reported.The getinge field service technician (fst) was on site for further investigation.The fst confirmed the failure.According to the fst the device did not have leakage or error message displayed.The last preventive maintenance was performed on december 2020.The fst has confirmed that a short circuit was caused by a broken wire jacket in the power supply unit.The short circuit has caused the device to turn off.The most probable root cause for the wire jacket to be broken is the aging of the device.It has been decided to not repair due to aging of the device.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 device is taken out of use.The review of the non-conformities has been performed on 2021-10-26 for the period of 2004-11-04 to 2021-10-23.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely to have contributed to the reported event.The product in question was produced in 2004-11-04.If significant information becomes available, the complaint will be reopened and necessary steps will be initiated.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program.Additional investigations, or corrective actions, will be implemented in the event of adverse trending.

• 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: 12770270
• MDR Text Key: 280456751
• Report Number: 8010762-2021-00592
• 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: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose