MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG PEDIATRIC ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	96820-110
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: visual inspection shows evidence of damage/separation of the cannula body.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during an ecmo case using a bio-medicus pediatric arterial cannula it was noted on the fourth day there was blood noted leaking from the metal strip about 1 cm from the end of the metal part.The bleeding increased within a few seconds, ecmo was closed, full ventilation with increased adrenaline dose was begun.The patients blood pressure lowered, they lost blood, received 2 doses of adrenalin and a pack of blood cells.The cannula was replaced and patient connected to the ecmo system again.The patient has a exacerbation of pulmonary edema.The customer noted that patient had normal measurements 5 minutes prior to the leak.Customer commented that the cannula did not look straight when removed from the packaging.
Additional Manufacturer Narrative
Conclusion: it is deemed that a severe physical force would be needed to inflict damage on this cannula.The device history record was reviewed with no abnormalities reported.All the pictures of the reported lot number were reviewed to see if the damage occurred on manufacturing with no issues detected, all cannulas appeared to be in good condition when packaged and leaving the manufacturing plant.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIO-MEDICUS NG PEDIATRIC ARTERIAL CANNULA
• 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: 8174653
• Report Number: 2184009-2018-00046
• Device Sequence Number: 13959537
• Product Code: DWF
• UDI-Device Identifier: 00643169623101
• UDI-Public: 00643169623101
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K143083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2021
• Device Model Number: 96820-110
• Device Catalogue Number: 96820-110
• Device Lot Number: 214139208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 12/02/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 MO
• Patient Weight: 2