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

Model Number IB0595570

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

According to the reporter, the machine was set up for a patient treatment and during the priming phase the nurse noticed that the fluid was leaking from the pre-filter pressure transducer area.Priming was stopped and the preassembled device was taken down, and a second device from the same lot was used and had the same issue and so it was replaced with another product.Then a new treatment was started with the new preassembled device., it was also stated that during normal patient therapy, user noticed a large blood leak (within the preassembled device, within the dialyzer and also in the effluent line and inf/dia line closest the dialyze).The therapy was stopped early, and the patient was disconnected from the machine, the preassembled device was also taken down, and a new treatment was started with a new preassembled device to resolve the issue and the treatment was completed.Alarms were activated (first occurrence during priming- alarm 33 minimum pre-filter pressure was displayed.During therapy alarm 28 blood leakage from filter was displayed.).No other defects/damages found on the product where the leak was observed, intervention/treatment was not required as a result of the leakage, and no component was replaced.There was no medical treatment provided to the patient due to the event, there was no blood loss and blood transfusion was not required.There was no reported patient injury.

Manufacturer Narrative

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

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.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 machine was set up for a patient treatment and during the priming phase the nurse noticed that the fluid was leaking from the pre-filter pressure transducer area.Priming was stopped and the preassembled device was taken down, and a second device from the same lot was used and had the same issue and so it was replaced with another product.Then a new treatment was started with the new preassembled device., it was also stated that during normal patient therapy, user noticed a large blood leak (within the preassembled device, within the dialyzer and also in the effluent line and infusion/dialysate (inf/dia) line closest the dialyzer).The therapy was stopped early, and the patient was disconnected from the machine, the preassembled device was also taken down, and a new treatment was started with a new preassembled device to resolve the issue and the treatment was completed.Alarms were activated (first occurrence during priming- alarm 33 minimum pre-filter pressure was displayed.During therapy alarm 28 blood leakage from filter was displayed.).No other defects/damages found on the product where the leak was observed, intervention/treatment was not required as a result of the leakage, and no component was replaced.There was no medical treatment provided to the patient due to the event, there was no blood loss and blood transfusion was not required.There was no reported patient injury.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was blood leak.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: CARPEDIEM
• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13172183
• MDR Text Key: 287033054
• Report Number: 1000312731-2022-00001
• Device Sequence Number: 1
• Product Code: QIR
• UDI-Device Identifier: 08032979792282
• UDI-Public: 08032979792282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN180055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: IB0595570
• Device Catalogue Number: IB0595570
• Device Lot Number: 2106000214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1