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

Model Number	TL7Q72R6
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual analysis: visual inspection shows a fitting inside the returned device.Device was cleaned using a 10% bleach solution.Performance analysis: during the cleaning process the flow through the device was obstructed.The customer has stated this event was due to an error that happened on their end.The customer stated that the adapter was likely lodged inside a larger connector inside the accessory pouch of small items.When the customer attached the larger connector to the tubing, the adapter fell down into the venous line.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 it was noted that there was lower than expected venous drainage upon initiation of bypass.The surgeon opted to put an additional 24 fr venous cannula into the svc and attach it to a separate 3/8¿ venous line which the perfusionist connected to the cardiotomy venous reservoir port for drainage.The surgeon also placed an lv vent into the heart to decompress the ventricle.Those two interventions improved the venous return into the bypass circuit to allow for the team to complete the procedure.At the end of the case when the perfusionist filled the venous line with clear crystalloid solution to allow him to process the blood in the line and return it to the patient he noted that a perfusion adapter was actually inside the 1/2¿ venous line tubing near the venous line port on the cardiotomy venous reservoir.It is unknown if there were any adverse patient effects.The customer has stated this event was due to an error that happened on their end.The customer stated that the adapter was likely lodged inside a larger connector inside the accessory pouch of small items.When the customer attached the larger connector to the tubing, the adapter fell down into the venous line.

• 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: 8726306
• Report Number: 9612164-2019-02495
• Device Sequence Number: 2021751
• Product Code: DWF
• UDI-Device Identifier: 00763000247829
• UDI-Public: 00763000247829
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 06/24/2019

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: 01/31/2021
• Device Model Number: TL7Q72R6
• Device Catalogue Number: TL7Q72R6
• Device Lot Number: 217159211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/24/2019
• 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