MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 10031 #AVALON ELITE 31F, 31CM; NONE

Model Number 70106.3538

Device Problem Restricted Flow rate (1248)

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

Event Type  Injury  

Event Description

It was reported that during pt treatment the surgeon felt the cannula was very positional.Specifically the device needed readjusting to obtain the desired flow.No additional info is available since the event took place a year ago.(b)(4).

• Brand Name: 10031 #AVALON ELITE 31F, 31CM
• Type of Device: NONE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4802748
• MDR Text Key: 16067747
• Report Number: 3008355164-2015-00110
• Device Sequence Number: 1
• Product Code: DWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2015,04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70106.3538
• Device Catalogue Number: 10031#AVALON ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention