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

Catalog Number 70106.3538

Device Problems Break (1069); Hole In Material (1293); Material Integrity Problem (2978)

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

Event Date 07/09/2014

Event Type  Injury  

Event Description

It was reported that as a pt was being taken off of ecls (extracorporeal life support), a small pinhole was observed in the reinforced portion of the cannula.A dacron graft, tied with silk suture was used in the are of the pinhole.There was no reported pt effect.No reported delay in treatment.(b)(4).

Manufacturer Narrative

Maquet med sys, usa submits this report on behalf of the legal mfr of the device, maquet cardiopulmonary (b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.The device has been requested for return.A supplemental medwatch will be submitted when additional info becomes available.(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 CARDIOPULMONARY AG; kehler strabe 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4115442
• MDR Text Key: 4703906
• Report Number: 8010762-2014-00298
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2014,07/10/2014

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 Catalogue Number: 70106.3538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2014
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention