MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS ONE PIECE FEMORAL CANNULA KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96530-017

Device Problems Disconnection (1171); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, visual inspection of the opened device showed the fitting was not connected to the cannula.After investigation at medtronic and vention, the complaint was confirmed, the connector was not bonded to the cannula body.This is the result of a manufacturing error.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during unpackaging, the customer observed the fitting was not connected to the body of the cannula.The product was replaced with another and not used for a case.There was no patient involvement in this product issue.

• Brand Name: BIOMEDICUS ONE PIECE FEMORAL CANNULA KIT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6564857
• MDR Text Key: 75105160
• Report Number: 2184009-2017-00019
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00613994489982
• UDI-Public: 00613994489982
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K884129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 96530-017
• Device Catalogue Number: 96530-017
• Device Lot Number: 2016111235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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