MEDTRONIC MEXICO S. DE R.L. DE CV CUSTOM TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number HY11B40R1 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Sepsis (2067); Respiratory Failure (2484)
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Event Date 01/15/2021 |
Event Type
Death
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use of this custom pack a patient expired.Additional information received: circuit (lot #220911913) was in use from (b)(6) 2021 @ 0659 until (b)(6) 2021 @ 1643.Circuit 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multiple circuit changes and interventions and remained on ecmo support until the time of her death when support was withdrawn.Blood culture (aerobic) collected (b)(6) 2021 at 1405 was positive for (b)(6).Patient was receiving vancomycin, fortaz, and fluconazole at time of death.Cause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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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 (b)(6) 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 products 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.
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Event Description
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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 (lot #220911913) was in use until (b)(6) 2021 @ 1643.Both 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.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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