MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CUSTOM TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number HY10J00R6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Respiratory Failure (2484)

Event Date 01/15/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use of this custom pack a patient expired.Additional information received: circuit (lot #220768819) was in use from (b)(6) 2020 @ 1740 until (b)(6) 2021 @ 0659 at which time device was replaced.Circuits was replaced electively for thrombus/plaque formation throughout circuit.Patient was prenatally diagnosed with right cdh and was placed on va ecmo on dol 1 for respiratory failure and persistent pulmonary hypertension, despite maximum medical management.Cdh was repaired (b)(6) 2020, patient endured a complicated postoperative course related to intraabdominal/intrathoracic bleeding requiring multiple re-explorations and chest tube placement.Patient had an extensive ecmo course with multiple circuit changes and interventions and remained on ecmo support until the time of her death when support was withdrawn.Blood culture (aerobic) collected (b)(6) 2021 at 1405 was positive for (b)(6).Patient was receiving vancomycin, fortaz, and fluconazole at time of death.Cause of death is documented as perinatal respiratory failure associated with persistent pulmonary hypertension, congenital pulmonary hypoplasia from congenital diaphragmatic hernia with a secondary diagnosis of sepsis.There is no autopsy currently available.

Manufacturer Narrative

Additional information received confirms - patient was on ecmo from day 1 at cob until the time of death.Multiple circuits would mean at least 4 (at least 1 before and 1 after the two circuits identified above) 5 total circuit changes throughout the ecmo course.The 2 affected circuits were back to back in the middle of the run.There were 2 prior circuits before the first affected one, and 1 circuit after the second affected circuit.Medwatch form submitted to fda on 17-feb-2021.User facility report number (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The device history record reviews, including the sterilization lot records review, were performed on the devices; there were no correlations / issues identified regarding manufacturing.The devices were terminally sterilized using an ethylene oxide method validated to a minimum sterility assurance level of 10-6.(b)(6) is not resistant to the validated sterilization method used for these devices.S.Aureus is a gram-positive cocci and would pose no bacterial endotoxin risk as the lipopolysaccharides for endotoxin are only found in the cell wall of gram-negative bacteria.There is no increased risk of s.Aureus infection due to the potential presence of bacterial endotoxin.There were no non-conformances (ncmrs) identified and no reworks/deviations noted against the devices.The devices were manufactured per approved and released manufacturing processes and the devices met all applicable manufacturing specifications prior to release for distribution.Based on the information given, it appears that the cause of death was multifactorial i.E.Patients anatomy and reoperations.Product analysis could not be performed as the product will not be returned to medtronic.Based on all information, there is no evidence suggesting the device caused or contributed to the patients death.Based upon this assessment, there are no new risks associated with the use of this device as no new failure modes or use conditions of the system have been observed.There have been no device discrepancies identified and therefore no product changes are necessary.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Upon execution of fca cvg-21-q3-23 medtronic received information that during use of this custom pack a patient expired.Additional information received: circuit pli 10 (lot #220768819) was in use from (b)(6) 2020 @ 1740 until (b)(6) 2021 @ 0659 at which time device was replaced.Circuits were replaced electively for thrombus/plaque formation throughout circuit.Patient was prenatally diagnosed with right cdh and was placed on va ecmo on dol 1 for respiratory failure and persistent pulmonary hypertension, despite maximum medical management.Cdh was repaired (b)(6) 2020 patient endured a complicated postoperative course related to intraabdominal/intrathoracic bleeding requiring multiple re-explorations and chest tube placement.Patient had an extensive ecmo course with multiple circuit changes and interventions and remained on ecmo support until the time of her death when support was withdrawn.Blood culture (aerobic) collected (b)(6) 2021 at 1405 was positive for staphylococcus aureus (mrsa).Patient was receiving vancomycin, fortaz, and fluconazole at time of death.Cause of death is documented as perinatal respiratory failure associated with persistent pulmonary hypertension, congenital pulmonary hypoplasia from congenital diaphragmatic hernia with a secondary diagnosis of sepsis.There is no autopsy currently available.Additional information received confirms - patient was on ecmo from day 1 at cob until the time of death.Multiple circuits would mean at least 4 (at least 1 before and 1 after the two circuits identified above)? 5 total circuit changes throughout the ecmo course.The 2 affected circuits were back to back in the middle of the run.There were 2 prior circuits before the first affected one, and 1 circuit after the second affected circuit.

Manufacturer Narrative

Incorrect manufacturer address provided in initial report.Updated in correction.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: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; ibramiento, 22226; bc ; MX
• MDR Report Key: 11403291
• MDR Text Key: 234389902
• Report Number: 9612164-2021-00837
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00763000304928
• UDI-Public: 00763000304928
• Combination Product (y/n): N
• PMA/PMN Number: K924529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HY10J00R6
• Device Catalogue Number: HY10J00R6
• Device Lot Number: 220768819
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 02/05/2021; 02/05/2021; 03/30/2021; 06/24/2021
• Supplement Dates FDA Received: 03/03/2021; 03/09/2021; 04/27/2021; 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2112641-02-02-2021-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29 DA
• Patient Weight: 5