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

Model Number	BB8Q36R11
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic has requested return of the complaint device from the customer for assessment.Return is pending.Investigation is ongoing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use, the customer reported separation between the custom tubing pack hub and the pig-tail tubing.The patient required a blood transfusion.
Additional Manufacturer Narrative
Visual analysis: visual inspection shows the luer fitting separated from the tubing.Performance analysis: 3 returned unopened packs from the customer were opened and the tubing/fitting samples were attempted to be separated by-hand with no failures.Investigation conclusion: information was received from the customer that the product was used for 24 hours.Per the ifu, the pack should only be used for up to 6 hours.Complaint trending for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.There were no adverse patient effects as a result of this incidence.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that after 24-hours use, the customer reported separation between the custom tubing pack hub and the pig-tail tubing.The product was replaced to complete the case.The patient lost about 300ml of blood and required a blood transfusion.

• Brand Name: NA
• 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: 8669720
• Report Number: 9612164-2019-02171
• Device Sequence Number: 16676898
• Product Code: DWF
• UDI-Device Identifier: 00763000079833
• UDI-Public: 00763000079833
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K924529
• 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): 07/03/2019

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: 07/18/2020
• Device Model Number: BB8Q36R11
• Device Catalogue Number: BB8Q36R11
• Device Lot Number: 216954528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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