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

Model Number	96530-017
Medical Device Problem Codes	Disconnection (1171); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 6564857
• Report Number: 2184009-2017-00019
• Device Sequence Number: 10916542
• Product Code: DWF
• UDI-Device Identifier: 00613994489982
• UDI-Public: 00613994489982
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K884129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1