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

Model Number HCU 30

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

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.According to the service report#: (b)(4) from 2020-12-03, the field service technician calibrated the actuator, and all function tests passed.The most probable root cause for the failure '1004-2' was the wrong setting of the 3-way valve (actuator).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 review of the non-conformities during the period of 2011-07-20 to 2020-12-07 does not show any non-conformity in regard to the reported product and failure.Thus, the reported failure ¿error 1004-2¿ could be confirmed.The event occurred during inspection.The hcu 30, which was used, was responsible for this complaint.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

Complaint #:(b)(4).It was reported that the hcu 30 showed error "1004-2 main heater temp.Sensor error".

• Brand Name: HEATER COOLER UNIT 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: 10981667
• MDR Text Key: 220684493
• Report Number: 8010762-2020-00430
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1