MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT HCU30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HCU 30

Device Problem Insufficient Heating (1287)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that the hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.The failure occurred during treatment.The hcu30 has been exchanged during use.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.The failure occurred during treatment.The hcu30 has been exchanged during use.No harm to any person has been reported.The hcu30 device has been checked by hospital itself, there was no investigation of a getinge field service technician.The reported failure could be confirmed by send picture of the displayed error message.Getinge has been informed that the reported failure was caused by a broken 3-way valve.The 3-way valve will be replaced.With reference to the hcu 30 service manual (hcu 30 | service manual | english | 07| hcu 30 | 9 troubleshooting | 110 |) when the temperature regulation works poorly or not at all and/or the cooling capacity is poor a possible cause for the failure is a defective 3-way valve.Furthermore, this failure may cause the error message ¿1004¿.Based on the evaluated facts above, the most probable root cause for the failure "hcu30 displayed the error message ¿1004-2 - main heater temp.Sensor error" could be determined as a broken 3-way-valve.The review of the non-conformities has been performed on 2023-11-28 for the period of 2015-05-26 to 2023-11-20.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.The product in question was produced in 2015-05-26.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 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: HEATER COOLER UNIT HCU30
• 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: 18235863
• MDR Text Key: 329320565
• Report Number: 8010762-2023-00591
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/19/2023
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention