MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLS SET ADVANCED 7.0

Catalog Number 701052794

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2013

Event Type  Injury  

Event Description

For the water lines from the customer's heater/cooler units, the customer typically uses (b)(6) brand of quick connects.(b)(6) recently purchased (b)(6) brand quick connects for replacement on heater/coller water lines.During a pt use for the hls set, the perfusionists were not able to place the hansen connectors on the water inlets/outlets for the hls set.They switched to the older connectors ((b)(6) brand) and had no further issues connecting water lines to the hls set.The customer also tested the same (b)(6) connectors on a competitive brand oxygenator and they were connected with difficulty.There were no effects to the pt.(b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365250
• MDR Text Key: 5288940
• Report Number: 3008355164-2014-00312
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2014,02/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2013
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention