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

Model Number HCU 30

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

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 30 showed the error ¿1004¿.Complaint id (b)(4).

Manufacturer Narrative

It was reported that the hcu 30 showed the error ¿1004¿ during cleaning cycle.A getinge field service technician (fst) was onsite and checked the hcu 30 device.The fst could confirm the reported failure due to a stuck 3-way valve.The fst has cleaned the 3way valve and the actuator.The cardioplegia heater connector has been replaced.The device has been tested for hour, no further alarms occured.The hcu 30 device is back in use.Thus the reported failure could be confirmed.The most probable root cause are residues on the 3-way valve.The review of the non-conformities has been performed on 2021-03-10 for the period of 2013-01-23 to 2021-03-10.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.

Event Description

Refernce number (b)(4).

• 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: 11284400
• MDR Text Key: 230431378
• Report Number: 8010762-2021-00099
• 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: 05/06/2021

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: HCU 30
• Device Catalogue Number: 70103.4642
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/06/2021
• Patient Sequence Number: 1