MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT MAQUET HCU 30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701034642 - HCU 30

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

During surgery, the error message when raise the temperature occurred.The perfusionist reported that the hcu 30 showed the error message "3004: cardiac protection side temperature error" when raise the temperature during surgery.After restart of the device no error occurred and the surgery could be continued.There was no harm to the patient.According to the service report #(b)(4) dated 2020-03-17 the getinge field service technician (fst) was onside and checked the device.The error could not be reproduced during repair and no parts had to be replaced.According to the service report the most probable root cause could be a shortage of water in the tank.Additional water was injected into the tank, after which the device could be used normally again.Function tests passed and the device is already back in use.Thus the reported error message when raise the temperature could not be confirmed.The reported failure happened during surgery.The hcu 30 which was used, was responsible for this complaint.The occurence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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.

Event Description

(b)(4).It was reported that the heater cooler unit hcu 30 displayed the error message "3004" during surgery, while trying to raise the temperature.When restarting the device the error did not occur again.No health problem for patients occurred.

• Brand Name: HEATER COOLER UNIT MAQUET HCU 30
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 9859029
• MDR Text Key: 199231137
• Report Number: 8010762-2020-00112
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701034642 - HCU 30
• Device Catalogue Number: 701034642
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1