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

Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913); Filtration Problem (2941)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported on (b)(6) 2012 that the customer was experiencing clot formation in the arterial outlet of cardiohelp hls sets.No further information was provided.(b)(4).

Manufacturer Narrative

This event was identified as being reportable during a retrospective review of complaint records as required by maquet's capa process.Due to the age of the complaint, follow-up will not be conducted and no further information is expected.

• Brand Name: HLS SET ADVANCED 7.0
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 3809688
• MDR Text Key: 4478545
• Report Number: 3008355164-2014-00089
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 05/01/2014,07/12/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2014
• Distributor Facility Aware Date: 07/12/2012
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention