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 Type  malfunction  

Event Description

Complaint (b)(4).It was reported that the hcu30 had a slow temperature rise on the cardioplegia side.The event occurred during treatment.The device was not replaced.No harm to any person was reported.

Manufacturer Narrative

It was reported that the hcu30 had a slow temperature rise on the cardioplegia side.Further investigation is on-going.A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that the hcu30 had a slow temperature rise on the cardioplegia side.The event occurred during treatment without any device replacement.No harm to any person was reported.A getinge field service technician (fst) was on site and investigated the affected hcu 30 (serial#(b)(6).The fst could confirm the reported failure, due to a defective 3-way valve actuator, which did not move smoothly and thus could not switch between hot and cold water normally.The fst disassembled and cleaned the solenoid valves and actuator and replaced the old actuator with the new version as a precaution (material#70103.4052).The device was tested successfully for full functionality.The most probable root cause for the reported failure were soiled 3-way valve actuator which did not move smoothly.After cleaning the "valves" and actuator the device worked as intended.The hcu 30 3-way valve actuator was replaced as a precaution.Furthermore, according 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 actuator.The review of the non-conformities has been performed on 2022-05-06 for the period of 2017-09-17 to 2022-04-21.It does not show any non-conformity in regard to the reported product and failure.Production related influences are unlikely to have contributed to the reported failure.The product in question was produced in 2017-09-17 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.

Event Description

Complaint id (b)(4).

• 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: 14314552
• MDR Text Key: 291307323
• Report Number: 8010762-2022-00139
• 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: 09/28/2022

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: 04/21/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 09/10/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose