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

Model Number IB7010250

Device Problem Product Quality Problem (1506)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/06/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient had neuroblastoma cancer with intermediate risk noted on the (b)(6) 2021 and admitted to the hospital on the (b)(6) 2021 for a scheduled round of chemotherapy.On the (b)(6) 2021, the patient was transferred to the pediatric intensive care unit (picu) requiring intubation and vasopressor support started on the (b)(6) 2021.The patient course was further complicated by typhlitis, acute renal failure, and liver dysfunction with resultant coagulopathy.The patient had acute respiratory failure with hypoxia and hypercapnia noted on the (b)(6) 2021.On the (b)(6) 2021, the patient condition had worsened and on the (b)(6) 2021, the patient became bradycardic that progressed to asystole.No cardiopulmonary resuscitation (cpr) was attempted due to parents direction and on the (b)(6) 2021, the patient died despite maximal ventilator settings and vasoactive support.The carpediem machine was not in use for continuous renal replacement therapy (crrt) treatment at the time of death.The patient death was not related and had no connection to the system/machine.The patient death was due to multi-system organ failure in the setting of pseudomonal septic shock secondary to typhlitis in the setting of protracted neutropenia due to chemotherapy for refractory neuroblastoma.The patient had history of cardiac, gastrointestinal, hematological, respiratory, urological problems.

Manufacturer Narrative

Additional information: a4 (weight in lbs), b5, g3 corrected information: h6 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.

Event Description

According to the reporter, the patient had neuroblastoma cancer with intermediate risk noted on the (b)(6) 2021 and admitted to the hospital on the (b)(6) 2021 for a scheduled round of chemotherapy.During this hospitalization, the patient was not treated with the machine (carpediem).On the (b)(6) 2021, the patient was transferred to the picu (pediatric intensive care unit), requiring intubation and vasopressor support started on the (b)(6) 2021.The patient course was further complicated by typhlitis, acute renal failure, and liver dysfunction with resultant coagulopathy.The patient had acute respiratory failure with hypoxia and hypercapnia noted on the (b)(6) 2021.On the (b)(6) 2021, the patient condition had worsened and on the (b)(6) 2021, the patient became bradycardic that progressed to asystole.No cpr (cardiopulmonary resuscitation) was attempted due to parents direction and on the (b)(6) 2021, the patient died despite maximal ventilator settings and vasoactive support.The machine (carpediem) was not in use for crrt (continuous renal replacement therapy) treatment at the time of death.The patient death was not related and had no connection to the system/machine.The patient death was due to multi-system organ failure in the setting of pseudomonal septic shock secondary to typhlitis in the setting of protracted neutropenia due to chemotherapy for refractory neuroblastoma.The patient had history of cardiac, gastrointestinal, hematological, respiratory, urological problems.There was no blood loss and no blood transfusion.No alarms activated.

• Brand Name: CARPEDIEM
• Type of Device: PEDIATRIC HEMODIALYSIS SYSTEM
• Manufacturer (Section D): BELLCO SRL; v camurana 1; mirandola,mo 41037 ; IT 41037
• MDR Report Key: 12555866
• MDR Text Key: 274078675
• Report Number: 1000312731-2021-00006
• Device Sequence Number: 1
• Product Code: QIR
• UDI-Device Identifier: 08051736003652
• UDI-Public: 08051736003652
• Combination Product (y/n): N
• PMA/PMN Number: DEN180055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IB7010250
• Device Catalogue Number: IB7010250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 13 MO
• Patient Weight: 12