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

Model Number HY2W85R16

Device Problems Fluid/Blood Leak (1250); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: 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
• MDR Text Key: 292808866
• Report Number: 9612164-2022-02033
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00763000515102
• UDI-Public: 00763000515102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/29/2022
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1