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

Model Number HCU 30

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

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

(b)(4).It was reported that the hcu 30 had the error 1004-2.

Event Description

Complaint #(b)(4).It was reported that the hcu 30 had the error 1004-2.

Manufacturer Narrative

The hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.According to the service report #(b)(4), the field service technician replaced the patient side actuator for 3-way valve (material number #701034052).All function tests passed.The most probable root cause for the failure '1004-2' were 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 2013-08-07 to 2021-01-12 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.

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11163773
• MDR Text Key: 226600783
• Report Number: 8010762-2021-00011
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1