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

Model Number 701044054 - HCU 40

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the hcu 40 had an electric spark at the bottom of the machine.The machine could not continue working.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

A life cycle engineering (lce) investigation was performed in order to determine the root cause of the reported issue.According to lce investigation report following was found: the most probable root cause is the influence of liquids within the power circuit.Thus the failure could be confirmed.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.

• 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: 8829930
• MDR Text Key: 163736095
• Report Number: 8010762-2019-00227
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701044054 - HCU 40
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1