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

Model Number HCU 30

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fst) was on site for further investigation and could confirm the failure "error 1004".Getinge fst confirmed that tests on the hcu 30 device are on-going.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint number #(b)(4).It was reported that the hcu 30 had intermittent error 1004-2.

Event Description

Complaint number #( b)(4).It was reported that the hcu 30 had intermittent error 1004-2.

Manufacturer Narrative

It was reported that the hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.The getinge field and service technician (fst) has been sent for investigation, on (b)(6) 2021.The fst confirmed the failure.According to the service report #43608400, the fst has replaced the actuator 24v ac/dc 50/60hz (material #70103.4052) and cleaned the 3-way valve.All function tests passed.The device is back in clinical use.Therefore, the most probable root cause for the failure "1004-2" is a defective actuator 24v ac/dc 50/60hz (material #70103.4052).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.Thus, the reported failure ¿error 1004-2¿ can be confirmed.The failure occurred during self-test.The hcu 30, which was used, was responsible for this complaint.The product in question was produced in (b)(6) 2013.The review of the non-conformities during the period of (b)(6) 2013 to (b)(6) 2021 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 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: 11372831
• MDR Text Key: 233321857
• Report Number: 8010762-2021-00131
• 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: 04/06/2021

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: 02/16/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1