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

Model Number HCU 30

Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the hcu 30 not turn on during a preparation for the emergency surgery.The start of the surgery has been delayed.Complaint number (b)(4).

Event Description

Complaint number (b)(4).

Manufacturer Narrative

It was reported that the hcu 30 not turn on during a preparation for the emergency surgery.The start of the surgery has been delayed.A getinge field service technician (fst) was sent for investigation on 2021-03-05.The fst confirmed the failure and replaced the mcp00703837 # control board , type 2 pc1891 (material#701034530), the current probe (material#701034527) and the mcp00703831 # power supply board, type 2 (material#701034529 ).The device passed all function tests and has been put back in use.A similar failure was investigated at getinge life cycle engineering on 2017-10-11 as part of a previous complaint.The most probable root cause is a high contact resistance which was probably caused by corrosion or a bad crimp connection.The device was manufactured on 2010-10-28.The review of the non-conformities has been performed on 2021-02-22 for the period of 2010-10-28 to 2020-12-31.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.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 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: 11160578
• MDR Text Key: 234339702
• Report Number: 8010762-2021-00008
• 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: 05/28/2021

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: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1