MAUDE Adverse Event Report: BELLCO SRL CARPEDIEM; PEDIATRIC HEMODIALYSIS SYSTEM

Model Number	IB7010250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	11/24/2022
Type of Reportable Event	Death
Event or Problem Description
According to the reporter, the infant was born via forceps assisted vaginal delivery.Forceps delivery resulted in subgaleal hemorrhage.An ultrasound was performed on (b)(6) 2022 and results showed subcutaneous hemorrhage.The subject was transferred to study hospital on day of birth with decompensation resulting in cardiac arrest, acute respiratory failure, and massive transfusion.The patient became massively fluid overloaded and treatment was started with the machine on (b)(6) 2022.On (b)(6) 2022, an ultrasound was performed on the head with a diagnostic result of parenchymal hemorrhage.Treatment with the machine was stopped on (b)(6) 2022 due to hemodynamic instability.Outside of the treatments with the machine on (b)(6) november, the subject was treated with mechanical ventilation and blood product administration.In addition, therapeutic hypothermia was used.The family decided to withdraw care on (b)(6) 2022 and the patient passed away.The death was not system-related.The machine system was used to treat the subject, however, treatment had been discontinued prior to the death.The blood loss that required blood transfusions was not due to the machine treatment but the hemorrhage that resulted due to birth.
Additional 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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: a5a, a5b, b2, b5, b7, e1 (first name, last name, phone number), e2, e3, e4 (email).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.
Event or Problem Description
According to the reporter, the infant was born via forceps assisted vaginal delivery.Forceps delivery resulted in subgaleal hemorrhage.An ultrasound was performed on (b)(6) 2022 and results showed subcutaneous hemorrhage.The subject was transferred to study hospital on day of birth with decompensation resulting in cardiac arrest, acute respiratory failure, and massive transfusion.The patient became massively fluid overloaded, anuric and cvvhd (continuous veno-venous hemodiafiltration) treatment was started with the machine on (b)(6).On (b)(6) 2022, an ultrasound was performed on the head with a diagnostic result of parenchymal hemorrhage.The treatment was completed and the treatment with the machine was stopped on (b)(6) 2022 due to hemodynamic instability.Outside of the treatments with the machine on (b)(6), the subject was treated with mechanical ventilation and blood product administration.In addition, therapuetic hypothermia was used.The family decided to withdraw care on (b)(6) 2022 and the patient passed away later that day.It was also stated that the principal investigator (pi) had indicated that the machine system was not related to the death.The machine system was used to treat the subject, however, treatment had been discontinued prior to the death.The subject was not on the machine at the time of death.The blood loss that required blood transfusions was not due to the machine treatment but the hemorrhage that resulted due to birth.Subgaleal hemorrhage was the cause of death.There was no issue/defect noted on the machine.No alarm/error code activated/displayed.No anticoagulant administered.Nothing unusual observed on the device prior to use.No machine components replaced.

• Brand Name: CARPEDIEM
• Common Device Name: PEDIATRIC HEMODIALYSIS SYSTEM
• Manufacturer (Section D): BELLCO SRL; v camurana 1; mirandola,mo 41037 ; IT 41037
• Manufacturer (Section G): BELLCO SRL; v camurana 1; mirandola,mo 41037 ; IT 41037
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16052337
• Report Number: 1000312731-2022-00005
• Device Sequence Number: 6394796
• Product Code: QIR
• UDI-Device Identifier: 08051736003652
• UDI-Public: 08051736003652
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: DEN180055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: IB7010250
• Device Catalogue Number: IB7010250
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/12/2023
• Date Device Manufactured: 03/26/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 7 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White