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

Model Number HCU 30

Device Problem Excessive Heating (4030)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hcu 30 could not lower the temperature of the circulating water on the main side, and ice melted.The failure occurred during patient treatment.No indication of actual or potential for harm or death.A getinge field service technician (fst) will be sent for investigation.A follow up medwatch will be submitted when new information becomes available.

Event Description

The temperature of the circulating water on the main side became difficult to lower during surgery.The temperature drop on the cardioplegia side did not seem to be a problem.The chunks of ice in the tank had melted, especially on the main side.The surgery was replaced with another hcu30 and continued.Therefore, there was no problem with the surgery and the patient.Complaint#(b)(4).

Event Description

Complaint id (b)(4).

Manufacturer Narrative

It was reported that the hcu 30 could not lower the temperature of the circulating water on the main side, and ice melted.The failure occurred during patient treatment, the device was replaced with a back up unit.No harm or death 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 ice sensor.The fst replaced the hcu 30 ice sensor (material#70103.4528) and tested the device successfully for full functionality.Thus the reported failure could be confirmed.The most probable root cause for the ice melting is a defective ice sensor due to corrosion caused by water and cleaning agents.The product in question was produced in 2009-02-03.The review of the non-conformities has been performed on 2022-01-13 for the period of 2009-02-03 to 2021-08-04.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 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
• 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: 12317576
• MDR Text Key: 266365816
• Report Number: 8010762-2021-00445
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 70103.4642
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2009
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose