MAUDE Adverse Event Report: PERFUSION SYSTEMS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	CB7U79R12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of the custom tubing pack line 5 of the tubing "popped off" of connector and air was introduced to the patient.Patient was treated with cpr for 7.5 minutes.The circuit was de-aired and re-initiated.Patient was extra corporeal membrane oxygenation (ecmo) dependant and has an oxygen saturation (sa02) of 6.
Additional Manufacturer Narrative
The tubing disconnected just right of the stopcock the issue occurred after several days of use.The user used this product outside of its indicated use, the indicated use is up to 6 hours and it was stated it was used for several days.If information is provided in the future, a supplemental report will be issued.

• 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: 8572440
• Report Number: 2184009-2019-00017
• Device Sequence Number: 2087175
• Product Code: DWF
• UDI-Device Identifier: 00763000021924
• UDI-Public: 00763000021924
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 05/23/2020
• Device Model Number: CB7U79R12
• Device Catalogue Number: CB7U79R12
• Device Lot Number: 215858101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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: 18 YR
• Patient Weight: 55