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

Model Number HCU 30

Device Problem Insufficient Heating (1287)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Further information has been requested but has not yet been received.

Event Description

It was reported that the hcu 30 showed the error ¿3004 card.Heater temp.Sensor error¿.The failure occurred during patient treatment.The device has been restarted.No patient harm occurred.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the hcu 30 displayed the error message "¿3004 card.Heater temp.Sensor error¿.The failure occurred during patient treatment.No patient harm occurred.A getinge service technician was on site on 2021-09-01 to repair the affected hcu 30 (serial#(b)(6)).The technician actuator (material#701084052) and the 3-way valve (material#701020563).The device is working as intended.An investigation of a hcu 30 system that exhibited a similar issue "3 way valve" was performed in getinge life cycle engineering (lce) on 2018-04-27.The most probable root cause could be determined as: the valve was strongly polluted on the inside and on the thread.Furthermore the valve had several scratches on the outside.The pin, which is responsible for opening and closing the valve, could be moved.However in the beginning moving the pin was more difficult.This indicates that the pin could have been blocked by the pollution.After connecting the valve to an test actuator an voltage between 0 v and 10 v was applied for several times.The valve opened and closed without any failure.No malfunction was found when the valve was tested in the closed state.However, it is possible that the high level of the pollution of the valve was caused by shocks to the valve during shipping.The pin in the valve may have been therefore slackened, which is why the pin could be moved again during the investigation.As stated by the lce the actuator controls the 3 way valve.Therefore, a possible root cause could be determined as a defect actuator that did not control the 3 way valve.The hcu 30 has been phased out in 2010.The technical support, in house repairs, as well as spare parts supplies have been discontinued in 2017.Based on these investigation results the reported failure could be confirmed the product in question was produced in 2010-10-15.The review of the non-conformities has been performed on 2021-09-22 for the period of 2010-10-15 to 2021-08-04.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.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.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.

Event Description

Complaint id: (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: 12286439
• MDR Text Key: 265349002
• Report Number: 8010762-2021-00432
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HCU 30
• Device Catalogue Number: 701034642
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 10/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention