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

Model Number HCU 30

Device Problem Failure to Pump (1502)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

It was reported that the hcu 30 had issues with the water pump.The circulation pump on the main side of the device was not rotating.The failure occurred during clinical use.The affected device was replaced during use.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The getinge field service techncian (fst) has confirmed that after clinical, when the customer checked the affected device, the reported pump issues were not reproducible.Further investigation is on-going.A follow-up medwatch will be submitted when additional information becomes available.Further information has been requested but has not yet been received.

Manufacturer Narrative

It was reported that the hcu 30 had issues with the water pump.The circulation pump on the main side of the device was not rotating.The failure occurred during clinical use.The affected device was replaced during use.No harm to any person has been reported.The getinge field service technician (fst) has confirmed that after clinical use, when the customer checked the affected device, the reported pump issues were not reproducible.The customer informed getinge sales and service unit (ssu), that no repair is needed as the device was tested and found to be working as intended.Based on the evaluated facts above the reported failure "water pump / circulation issues" could neither be reproduced nor confirmed.However, with reference to the hcu 30 revised instructions for use a probable root cause for the reported failure could be determined as kinked tubes.Revised instructions for use | 1.5 | en | 01 |hcu 30 | warning! if a water tube of the hcu 30 is kinked for more than 30 sec., the internal water temperature in the heater can rise and the associated pump stops.The operator may have to restart the water pump.The pump only starts when the internal water temperature has fallen below 41.3°c.Caution! do not kink the tubes.Do not touch the tubes with pointed or sharp objects.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 review of the non-conformities has been performed on 2023 (b)(6) for the period of 2011 (b)(6) to 2023 (b)(6).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 are unlikely to have contributed to the reported failure.The product in question was produced in 2011 (b)(6).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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17622239
• MDR Text Key: 321934069
• Report Number: 8010762-2023-00420
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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: 701028718
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention