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

Model Number HY8L55R5

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of a custom pack, it was reported that the customer was priming the circuit prior to patient entering the room and fluid leak was found coming from the pump head during gravity prime.The device was replaced.There was no patient involvement, so no adverse effect occurred.

Manufacturer Narrative

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.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.

Manufacturer Narrative

Device evaluation summary: visual inspection showed evidence of a crack under the qb-inlet port.The device was primed and run from 0-4000 rpms on a bio-console and during the run there was a leak observed from the crack.The reason for return was confirmed.Conclusion: the complaint was confirmed for leaking based on the photo provided by the customer and the product analysis performed.An analysis of this occurrence could be performed with the returned product.During the process review, an attempt was made to replicate the defect and it could not be replicated.After evaluation of this complaint, the root cause of the defect could not be determined.A process review was performed, and no opportunities or risk were detected.Assembly personnel and supplier were notified about this complaint.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received for the same failure modes were reviewed and showed no trends warranting escalation related to this occurrence.Assessment against the medtronic risk management file indicated that the current risk zone does not exceed the risk zone predicted in the product process failure mode effects and criticality analysis (pfmeca).There were no adverse patient effects because of this incident.Medtronic will continue to monitor for future occurrences and trends.Correction b5: medtronic received additional information that the same leak did not appear in multiple packs.The leak was from the inlet portion of the custom tubing pack.The leak originated from the component.There was no visible air in the system/tubing.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: MEDTRONIC TUBING PACK
• Type of Device: OXYGENATOR, 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: 17085301
• MDR Text Key: 316757847
• Report Number: 9612164-2023-02452
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00643169572263
• UDI-Public: 00643169572263
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171979
• 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,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HY8L55R5
• Device Catalogue Number: HY8L55R5
• Device Lot Number: 225699309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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