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

Model Number BTC93

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

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 during use when the customer was processing the blood, they noted a crack at the y-connector of the btc93.Customer coated it with bone wax and continued with the case.There was no adverse effect to the patient.

• 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: 8137382
• MDR Text Key: 129614092
• Report Number: 2184009-2018-00038
• Device Sequence Number: 1
• Product Code: CAC
• 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

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BTC93
• Device Catalogue Number: BTC93
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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