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

Model Number SL-2010M2096A

Device Problems Loose or Intermittent Connection (1371); Air/Gas in Device (4062)

Patient Problem Hemorrhage/Bleeding (1888)

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: event 1: customer reports a defective lot of bloodlines unable to return blood to the patient due to active white site on the saline tubing.The reporter clarified that the luer lock port on the saline line will not pull saline through the line just pulls air instead the port will not release, puncture, or unlock.This device malfunction occurred during use on a patient.Subsequently the staff were not able to return a good amount of the blood pack into the patient.Approximately 50 ml of blook was left in the arterial tubing.The reporter confirmed that no additional medical intervention was required but cautioned that had the event occurred more than once on a person if could lead to patient harm due to substantial blood loss the reporter added that sometimes when this malfunction occurs the user can unscrew and recrew the luer lock port or they can open up a different clamp and the saline can go through by bypassing the blocked y site; this was you can return a good amount of the blood but not all of it.

Manufacturer Narrative

Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Thirteen unused samples in the original package were returned for evaluation.Samples were visually evaluated, and no defects were observed.All samples were occlusion tested with passing results.In an attempt to replicate the reported defect, all samples were attached to a water line, and all locksites were tested by pushing and pulling fluid through a syringe, one out of the thirteen samples, the fluid did not freely flow through locksite.Based on the results of the sample evaluation, the reported defect was confirmed.Exact root cause cannot be determined at this time, but user mishandling cannot be ruled out at this time.It is possible that improper use of the product could lead to the inability to rinse back.All available information regarding this occurrence has been forwarded to our mrb in order to heighten awareness.Retained units were evaluated and passed the internal testing.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Additionally, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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 DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17162269
• MDR Text Key: 317672372
• Report Number: 2523676-2023-00294
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046955674992
• UDI-Public: (01)04046955674992
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2010M2096A
• Device Catalogue Number: SL-2010M2096A
• Device Lot Number: 00VL862406
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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