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

Model Number 701034642 - HCU 30

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

No consequences or impact to patient.A follow up medwatch will be submitted when additional information becomes available.

Event Description

Complaint (b)(4).During heart surgery, the power to the hcu30 was cut off by itself.The power switch was in the "on" state.The equipment was restored by the perfusionist turning it back on.The hospital uses only the main circuit of hcu 30.After the restart the device was functioning again, therefore there was no impact on the patients or the extended surgery.

Manufacturer Narrative

The hcu 30 was cut off by itself.The most probable root cause of the cut off is that the mains fuse (250v, 8a) in the power supply unit at the bottom of the unit was blown.According to the hcu 30 risk analysis version v04 (dms# (b)(4)) the most probable root causes:inadequate function because of e.G.:- design error- technical failure- production failure- service failure- shipping error- software failure the reported failure "was cut off by itself" can be confirmed.The failure occurred during surgery.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 (b)(4).

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• MDR Report Key: 10066708
• MDR Text Key: 191322921
• Report Number: 8010762-2020-00168
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701034642 - HCU 30
• Device Catalogue Number: 701034642
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1