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

Model Number BTC93

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2018

Event Type  malfunction  

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 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
• Type of Device: APPARATUS, AUTOTRANSFUSION
• 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: 8137359
• MDR Text Key: 129600619
• Report Number: 2184009-2018-00037
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00673978522548
• UDI-Public: 00673978522548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2184009-11-30-2018-003-R
• Patient Sequence Number: 1