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

Model Number HEATER COOLER UNIT

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hcu40 had a leak on the hanssen coupling (hose side) during preparation.The incident occurred during priming.No known patient was involved.(b)(4).

Event Description

It was reported that the hcu40 had a leak on the hanssen coupling (hose side) on startup of device.(b)(4).

Manufacturer Narrative

According to the e-mail from the ssu dated on 2019-11-14: the affected hose couplings have been replaced.The hcu were reinstalled after the couplings and hoses had been replaced.Thus the reported failure "leaking hanssen coupling" could be confirmed.No root cause determination is applicable, the defective part is not available for investigation.The occurence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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: MAQUET HCU 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9097558
• MDR Text Key: 181976136
• Report Number: 8010762-2019-00292
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEATER COOLER UNIT
• Device Catalogue Number: 701054917
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1