MAUDE Adverse Event Report: PERFUSION SYSTEMS Y ADAPTER; APPARATUS, AUTOTRANSFUSION

Model Number	BTC93
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual analysis: visual inspection shows evidence of a crack at the base of the "y" connector.Performance analysis: pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing, there was a small leak observed at the base of the "y" connector.Conclusion: the leakage reported only occurs in those assemblies that used cavity 1.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that prior to use the suction and anticoagulant line leaked when the customer hooked it up to saline.The product was replaced.There was no patient involved so no adverse effect occurred.

• Brand Name: Y ADAPTER
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8137359
• Report Number: 2184009-2018-00037
• Device Sequence Number: 16208855
• Product Code: CAC
• UDI-Device Identifier: 00673978522548
• UDI-Public: 00673978522548
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K812292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2021
• Device Model Number: BTC93
• Device Catalogue Number: BTC93
• Device Lot Number: 215691545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2184009-11-30-2018-003-R
• Patient Sequence Number: 1