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

Model Number HCU 30

Device Problems Corroded (1131); No Display/Image (1183); Fluid/Blood Leak (1250); Infusion or Flow Problem (2964); Temperature Problem (3022)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

Further information regarding the repair of the device have been requested.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 showed the error ¿1004-2 main heater temp.Sensor error¿, and that there was a leak in the main side female connector.

Event Description

Complaint number#: (b)(4).It was reported that the hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.Furthermore, during investigation, there was a leak in the main side female connector, the device showed low flow, display screen and temperature probes did not function, and the hoses were corroded.

Manufacturer Narrative

It was reported that the hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿ during selftest.Furthermore, during getinge field service technician (fst) visit the hcu 30 also showed leak in the main side female connector, low water flow, screen defective and rusty hoses.Regarding error 1004-2: the getinge field service technician was on site and confirmed the failure 1004-2.In the examinations made on the device, it was observed that the device stopped due to a timeout during heating.The device went into error and stopped heating.Furthermore, according to the life cycle engineering, the most probable root cause for the error 1004-2 is a defective control board and defective temperature probe.The field service technician has requested the replace of mcp00705707# temperature sensor (pt1000) (material#: 70102.0517) and mcp00703837# control board, type 2 pc1891 (material#: 70103.4530).Regarding leak and low water flow: the getinge field service technician observed during examination that the flow of the water cycles were slow, as a result of 3-way valve obstruction.Furthermore, there was water leakage in the female connector on the main side of the device.According to the life cycle engineering and the field service technician the following most probable root cause for "low water flow" and "leak" can be identified as: aging of the female connector 1/2" which caused the leakage; aging and blockage by particles of 3-way-valve due to lack of maintenance which caused the low flow of water in the device.The field service technician has requested the replace of mcp00704473# female connector 1/2" (70102.9129) and mcp00460040# hcu 30 3-way-valve main (#: 70102.0562).Regarding failures screen defective and rusty hoses: the getinge field service technician observed during examination that the screen of the device turned black.Furthermore, corrosion was observed in the main and patient hoses of the device.According to communication with the field service technician, the probable root cause for both failures is aging.The hcu 30 has been phased out since the end of 2010.The technical support, in-house repairs, as well as spare parts supplies have been discontinued in 2017.The field service technician has requested the replace of mcp00938241# front foil hcu 30 (70102.0521), mcp00704733# operating panel hcu30 type 2 (70103.4524), hose set 1/2" (70106.2417) and bypass hose 1/2" (70106.2415).The device has been taken out of use, and the customer did not consider a repair up to now.The product in question was produced in 2011-04-28.The review of the non-conformities during the period of 2011-04-28 to 2021-05-28 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.In case new information is available the complaint will be re-opened and necessary steps will be initiated.

• 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: 11626266
• MDR Text Key: 244164221
• Report Number: 8010762-2021-00233
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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: 05/21/2021
• Patient Sequence Number: 1