MAUDE Adverse Event Report: MEDTRONIC MEXICO MEDTRONIC TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	TL10H15R2
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 connector came of the tubing.The pack will be replaced.The patient required a transfusion.
Additional Manufacturer Narrative
Updated information: the customer temporarily clamped off the pump, removed the broken connector and added a new pigtail.The patient lost 200 ml of blood as a result of the connector coming off.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Investigation conclusion; at this time root cause could not be determined.However, medtronic understands the client concern and in order to ensure no re-occurrence catalog specification was updated adding silicon bands to the 1160282-507 adapter and the 3/16 x 1/16 x 3 tubing solvent connection.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC TUBING PACK
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9178718
• Report Number: 9612164-2019-04315
• Device Sequence Number: 2592245
• Product Code: DWF
• UDI-Device Identifier: 00763000261863
• UDI-Public: 00763000261863
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171308
• 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,Followup
• Report Date (Section B): 11/19/2019

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: 07/24/2021
• Device Model Number: TL10H15R2
• Device Catalogue Number: TL10H15R2
• Device Lot Number: 218145037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 11/08/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/05/2019; 11/19/2019
• 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