MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 10031 #AVALON ELITE 31F, 31CM

Model Number 70106.3538

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2015

Event Type  Injury  

Event Description

It was reported that during use, the end of the introducer got caught in the silicone cap and was accidently advanced into the silicone cap of the cannula.This prevented the introducer from being pulled out of the silicone cap.Removing the introducer from the cap was only possible by removing the entire cap, pushing the introducer back on cannula.No reported pt effect.Product was replaced.Treatment was delayed 1-2 minutes due to this event.(b)(4).

• Brand Name: 10031 #AVALON ELITE 31F, 31CM
• Type of Device: AVALON ELITE 31F, 31CM
• 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: 4514328
• MDR Text Key: 5532232
• Report Number: 3008355164-2015-00019
• 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: 02/11/2015,01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2015
• Date Report to Manufacturer: 01/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR