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

Model Number	HY6T48R10
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Reaction (2414); Blood Loss (2597)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer discarded product.No analysis can be performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of a custom tubing pack the 3/16 tubing that connects to the manifold disconnected from the luer fitting that connects to the manifold.Air was then pulled into the manifold and the perfusion circuit.The patient required epinephrine administration and fluid resuscitation.
Additional Manufacturer Narrative
Additional information: the patient was being transported from the operating room to the cardiac icu following surgery when the ecmo shunt line tubing became disconnected from the manifold.This resulted in air entrapment in the tubing and blood loss.The patient required 5 minutes of cpr while the air was drawn back from the circuit and tubing was reconnected.Conclusion: all custom pack tubing configurations are assembled with approved methods and in specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CUSTOM TUBING PACK
• 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: 7812681
• Report Number: 2184009-2018-00025
• Device Sequence Number: 136372
• Product Code: DWF
• UDI-Device Identifier: 00643169783331
• UDI-Public: 00643169783331
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171979
• 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): 09/14/2018

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: 01/31/2020
• Device Model Number: HY6T48R10
• Device Catalogue Number: HY6T48R10
• Device Lot Number: 215510567
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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