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

Model Number 96820-110

Device Problem Material Separation (1562)

Patient Problem Pulmonary Edema (2020)

Event Date 12/01/2018

Event Type  Injury  

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 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.

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
• 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: 8174653
• MDR Text Key: 130673495
• Report Number: 2184009-2018-00046
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00643169623101
• UDI-Public: 00643169623101
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K143083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 02/04/2019
• Date Device Manufactured: 10/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO
• Patient Weight: 2