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

Model Number	BB12E50R3
Medical Device Problem Codes	Material Separation (1562); Component Missing (2306); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of a custom tubing pack, it was reported that the venous side of the pre-bypass filter had no zip tie.The customer stated that all packs in this lot number are missing the zip tie on the venous side of the pre bypass filter.The venous line slips off very easily.Their previous packs all had a zip tie holding the venous line to the pre-bypass filter.The loose/separated component did not fall into the patient.The device was used.There was no adverse patient effect associated with this event.Medtronic received additional information that the venous line is not disconnected in the custom pack prior to use.After priming, the av loop is opened and passed up to the sterile field with both the arterial and venous lines still connected to the pre-bypass filter.This need to be done with aseptic technique.It is during this manipulation of getting the lines onto the sterile field that the venous line slips off the connector on the pre-bypass filter.The complaint is that there is no tie band on the venous side of the pre-bypass filter.It should be noted that when this happens the surgical drapes become saturated with the priming solution.This can lead to ¿fluid breakthrough¿ which increases the risk of patient infection.Medtronic received additional information that they reconnect the lines using a 1/2 x 3/8 connector and recirculate the prime through the loop to ensure that they are de-aired.They have also reattached the venous line to the filter and had the scrub technician hold the components in place to do the same thing.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 20073862
• Report Number: 9612164-2024-03867
• Device Sequence Number: 6573760
• Product Code: DWE
• UDI-Device Identifier: 00763000932084
• UDI-Public: 00763000932084
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K171979
• 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): 08/27/2024

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: 12/13/2025
• Device Model Number: BB12E50R3
• Device Catalogue Number: BB12E50R3
• Device Lot Number: 228431032
• 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: 07/30/2024
• Initial Report FDA Received Date: 08/27/2024
• Date Device Manufactured: 03/07/2024
• 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