MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A

Model Number SL-2000M2095L

Device Problem Air/Gas in Device (4062)

Patient Problem Coagulation Disorder (1779)

Event Date 12/03/2022

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: detailed inquiry description approximately 20 min before the end of the treatment staff noticed air in the venous chamber and blood on the "air" side of the venous pod.Blood contaminated the venous pressure monitoring line and the machine venous pressure port.(see attached pictures).The patient has not been receiving heparin, therefore system was flushed hourly with approximately 200 ml of saline.The nurses reported that this patient have not had clotting problems in the past.In this case the system might have shown some signs of clotting.Treatment was terminated, blood returned.Machine was removed from use.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Four (4) photos depicting the sample and site of reported defect, along with the batch info label was returned from facility for evaluation.A visual evaluation was performed on the photographs returned and it was note that the arterial pod membrane was full and there were signs of blood in the venous pressure monitoring line which would is evidence of the pod membrane breaking allowing blood to flow out of pod.Based on the results of the visual evaluation of photographs returned the reported defect is confirmed.A potential root cause could be from the manufacturing machine, due to high pressure of return can stress the product and generate a perforation in the pod membrane.An approved project is in place to further address issues of this nature.A review of manufacturing records was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH A
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018 0027
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018 0027
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15971675
• MDR Text Key: 308479345
• Report Number: 2521402-2022-00171
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046955348909
• UDI-Public: (01)04046955348909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2000M2095L
• Device Catalogue Number: SL-2000M2095L
• Device Lot Number: A2200646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2022
• 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