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

Model Number IB0595580

Device Problems Coagulation in Device or Device Ingredient (1096); Product Quality Problem (1506)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient who had anemia required packed red blood cells (prbc) transfusion intermittently at baseline which was related to complications from hemophagocytic lymphohistiocytosis (hlh) and bone marrow transplantation (bmt).During the treatment, the patient had worsening anemia and that there was clotting of the two filters (single all-inclusive tubing/filter) in under 1 hour, which prevented blood return and resulted in 80 ml of blood loss.Hemoglobin test was performed and had a result of 6.5.There were no other diagnostic procedures performed.It did not result to the patient being hospitalized and the patient was not treated with an additional continuous renal replacement therapy (crrt) session.It did not have mechanical ventilation added or settings adjusted, no treatment with ecmo initiated or adjusted, and no treatment with medication (adjusted, added, or dose reduced).The machine was operating as expected.The adverse event was treated with blood products administration (blood transfusion) and the tubing set was replaced to resolve the issue.There were no other actions taken in response to the event.The procedure was completed.The patient had recovered.

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 patient who had anemia required packed red blood cells (prbc) transfusion intermittently at baseline which was related to complications from hemophagocytic lymphohistiocytosis (hlh) and bone marrow transplantation (bmt).During the treatment, the patient had worsening anemia and that there was clotting of the two filters (single all-inclusive tubing/filter) in under 1 hour, which prevented blood return and resulted in 80 ml of blood loss.Hemoglobin test was performed and had a result of 6.5.It was mentioned that it did not appear that there was a possibility of a patient reaction causing coagulation issues.There were no other diagnostic procedures performed.It did not result to the patient being hospitalized and the patient was not treated with an additional continuous renal replacement therapy (crrt) session.It did not have mechanical ventilation added or settings adjusted, no treatment with ecmo initiated or adjusted, and no treatment with medication (adjusted, added, or dose reduced).The machine was operating as expected.The adverse event was treated with blood products administration (blood transfusion) and the tubing set was replaced to resolve the issue.There were no other actions taken in response to the event.The procedure was completed.The patient had recovered.

• 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: 11516620
• MDR Text Key: 240687559
• Report Number: 1000312731-2021-00003
• Device Sequence Number: 1
• Product Code: QIR
• UDI-Device Identifier: 08032979792299
• UDI-Public: 08032979792299
• Combination Product (y/n): N
• PMA/PMN Number: DEN180055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

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
• Device Operator: Health Professional
• Device Model Number: IB0595580
• Device Catalogue Number: IB0595580
• Device Lot Number: 20850458
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 215 DA
• Patient Weight: 9