MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT HCU 30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HCU 30

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

It was reported that the hcu 30 temperature stopped rising during treatment.The hcu 30 has been replaced.No indication of actual, or potential for harm, or death.Complaint number # (b)(4).

Manufacturer Narrative

The hcu 30 temperature stopped rising and the water could not circulate during treatment.No impact on the patient.Surgery time has been extended.According to the field service technician the actuator 24 24 v ac/dc 50/60hz (materia#70103.4052) needs to be replaced.The hospital was advised by the sales and service unit not to use this hcu 30 anymore until the problem is solved.Confirmation for replacement is outstanding by the hospital.The most probable root cause were wrong setting of the 3-way valve actuator.The review of the non-conformities during the period of 2009-03-02 to 2020-12-14 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.¿.Thus the reported failure 'temperature did not rise' can be confirmed.The hcu 30 which was used, was responsible for this complaint.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

Complaint number # (b)(4).

• Brand Name: HEATER COOLER UNIT HCU 30
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10800279
• MDR Text Key: 215049768
• Report Number: 8010762-2020-00378
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1