MAUDE Adverse Event Report: MEDTRONIC MEXICO CUSTOM TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	HY2W85R16
Medical Device Problem Codes	Fluid/Blood Leak (1250); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
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 customer reported that they noticed leaking tubing on line 3 in the custom tubing pack.The leak was from the mvr bag, around the seal where the spike goes into the holding bag.The affected tubing was the 1/2 venous tubing connection to bag and 3/8 arterial tubing to bag.The customer stated that there was potential contamination since tubing had no caps on the open ends.The device was used.There was no patient impact associated with this event.Medtronic received additional information which reported that less than 1 cc of blood loss occurred.A transfusion was not required because of the blood loss.No air was noted in the system/tubing when the leak was observed.The perfusionist said that they thought this issue had happened one other time, however specific details were not available.

• Brand Name: CUSTOM TUBING PACK
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14522187
• Report Number: 9612164-2022-02033
• Device Sequence Number: 15069285
• Product Code: DWE
• UDI-Device Identifier: 00763000515102
• UDI-Public: 00763000515102
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

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: 10/05/2023
• Device Model Number: HY2W85R16
• Device Catalogue Number: HY2W85R16
• Device Lot Number: 223283251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/27/2022
• Date Device Manufactured: 11/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown