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

Model Number IB0595540

Device Problems Device Sensing Problem (2917); Protective Measures Problem (3015)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/06/2023

Event Type  Injury  

Manufacturer Narrative

D10 concomitant products: ib0595540, cc ib0595540, kit cvvhd 015 carpediem, (lot#: 2201000320).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, a 24-day-old patient was hospitalized.For spontaneous prematurity with acute anuric renal failure requiring peritoneal dialysis.During the dialysis session, the membrane of the pressure sensor on the dialysis machine cracked after 30 minutes of dialysis on the circuit.The problem repeated with another dialysis kit at the time of connection.The alarm was activated.There was no issue with the machine.Nothing unusual was observed, on the kit prior to use.Priming was done, and the result was normal.They ended the treatment, changed the kit with the same product id (identifier) to resolve the issue.And the treatment was completed with the replacement kit.The clinical consequences and current state of the patient were that two dialysis were delayed.The patient was released.Disorganization and lengthening of the duration of care for around an hour.The patient had little blood loss.And the exact volume lost was unknown.A blood transfusion was the intervention or treatment required as a result of the event.And the exact value of the volume was unknown.The blood transfusion was, due to the small loss of blood.The patient was premature and had a low volume of blood.That was why, even if the blood loss was small, the hcp (heath care professional) had to replace it.The patient was in stable condition, but the anuric renal failure still had to be treated.

• Brand Name: CARPEDIEM SYSTEM
• Type of Device: 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: 18751621
• MDR Text Key: 335935795
• Report Number: 1000312731-2024-00004
• Device Sequence Number: 1
• Product Code: QIR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: DEN180055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IB0595540
• Device Catalogue Number: IB0595540
• Device Lot Number: 2201000320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other