MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HEATER COOLER UNIT

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complaint number (b)(4).It was reported that hcu30 stopped the circulation of the piping when the water temperature was raised from the 21 ° c setting.

Event Description

Complaint number (b)(4).

Manufacturer Narrative

The hcu30 the error 3008/3064 occured.The field service technician (fst) was onsite and replaced the power supply board (material#70103.4529).The fst stated that the 8a fuse (material#70103.4045) was blown.All function tests passed.The device is back in clinical use.The defective part is not available for investigation, therefore no root cause determination is applicable.Thus the reported failure "error 3008/3064" could be confirmed.The reported failure happened during treatment.The hcu 40 which was used, was responsible for this complaint.The occurence rate regarding the above complaint is below the acceptance rate.Thus no remedial action required.The ocurrence 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: MAQUET HCU 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9248968
• MDR Text Key: 200465824
• Report Number: 8010762-2019-00340
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEATER COOLER UNIT
• Device Catalogue Number: HCU 30, 701028718
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR