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

Model Number BB11G87R3

Device Problems Fracture (1260); Component Missing (2306)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: visual inspection showed a white luer cap was missing from the cardiotomy venous reservoir and the port on top of the turret was broken off in the section of tubing.The reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to use of a custom tubing pack, the customer reported that they observed damaged components inside the custom tubing pack when they opened it.The customer stated that the fusion oxygenator and cardiotomy venous reservoir (cvr) was missing some white caps and the line that was supposed to be pre-connected to the prime port in the center of the cvr lid was completely snapped off with the prime port broken off inside the prime line tubing.The customer stated that there was no apparent damage to the exterior shipping box, the plastic pack tray or the tyvek sterile pack cover.The customer stated that everything else inside the custom tubing pack was completely normal and that the cvr was securely in its nest in the bottom of the tray.The customer said it seems like the damage occurred prior to the cvr being strapped into the custom tubing pack tray.The device was repl aced to complete the procedure.There was no patient involvement so no adverse effect occurred.

Manufacturer Narrative

Correction b5: the broken prime port was completely broken off prior to use.This would make the device unusable for the procedure, and so there is no risk of patient death or serious injury.Correction d2: dwe conclusion: complaint is confirmed for ¿damaged component¿.After evaluation the cause of this complaint could not be determined.The manufacturing process was reviewed, and it was identified all controls are in place to prevent this non-conformance during assembly.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 13868462
• MDR Text Key: 288390393
• Report Number: 9612164-2022-01120
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00763000605292
• UDI-Public: 00763000605292
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: BB11G87R3
• Device Catalogue Number: BB11G87R3
• Device Lot Number: 223130152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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