MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 10027#AVALON ELITE 27F, 31CM

Model Number 70106.3537

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2014

Event Type  Injury  

Event Description

It was reported that while in use on a patient, they were unable to obtain the flow needed on the arterial side.There was high pressure with act above 200.The device was replaced with another and flow was restored to what was expected.No reported patient effect.(b)(4).

Manufacturer Narrative

A supplement medwatch will be submitted when additional information becomes available.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary received and investigated the "10027#avalon elite 27f" device.A visual inspection and a check on the patency of the device was performed.No damage or kinks could be found.The patency was checked by flushing the device with water, which did not show any abnormalities.The reported failure could not be confirmed.Requested information about the use of an appropriate imaging technology while advancing, positioning and placing of the guide wire and the catheter for this particular case; however no information was provided.Due to the insufficient information provided, a malfunction could not be confirmed and root cause could not be determined.

Event Description

(b)(4).

• Brand Name: 10027#AVALON ELITE 27F, 31CM
• Type of Device: AVALON ELITE 27F, 31CM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4297116
• MDR Text Key: 17694133
• Report Number: 8010762-2014-01276
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2014,10/16/2014

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 Model Number: 70106.3537
• Device Catalogue Number: 10027#AVALON ELITE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2014
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 64 YR
• Patient Weight: 73