MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HEATER-COOOLER UNIT

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

Further evaluation still in progress.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that the hcu40 vacuum valve had a leakage.Water dropped on the pcb.The pcb was burned.No patient involvement.(b)(4).

Manufacturer Narrative

The field service technician (fst) was onsite for further investigation.The fst replaced the hcu40 printed circuit board (pcb).A life cycle engineering (lce) investigation was performed in order to determine the root cause of the reported issue.According to lce investigation report the visual inspection shows deposits/dirt/impurities on the board and its connector-pins.The reported failure could be reproduced and most probable root cause could be traced to influence of electrical conductivity liquid to the printed circuit board.Thus the failure could be confirmed.There is no significant trend on this failure, therefore it cannot be concluded that production related influences could have led to the reported issue.Patient code: 2645.Device code: 1198.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Initial reference: (b)(4).(b)(6).

Manufacturer Narrative

The field service technician (fst) was onsite for further investigation.The fst replaced the hcu40 printed circuit board.The defective part has been received to life cycle engineering (lce)for further investigation and root cause analysis.A follow up medwatch will be submitted when additional information becomes available.

Event Description

Initial reference: (b)(4).Customer reference: (b)(4).

• Brand Name: MAQUET HCU 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8587476
• MDR Text Key: 144985012
• Report Number: 8010762-2019-00122
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEATER-COOOLER UNIT
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1