MAUDE Adverse Event Report: B. BRAUN MEDICAL INC HEMODIALYSIS BLOODLINES; BLOOD TUBING SETS

Model Number SL-2010M2096

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.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 user facility: at initiation of treatment the technician was tightening the venous tubing attached to the dialyzer when it completely separated from the dialyzer connector.The blood pump stopped.There was minimal blood loss.A new setup was completed and treatment was provided without any further problems.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved was not returned to the manufacturer for evaluation.A photograph of the dialyzer was provided for evaluation.The complaint was confirmed as the connector appears to be disconnected from the tubing.The photograph was provided to manufacturing for review.Manufacturing was unable to determine a root cause for this issue based on the available information.A review of the device history records for sl-2010m2096, lot 10354003, was performed and no quality issues occurred during the manufacturing process of this lot related to the reported event.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: BLOOD TUBING SETS
• 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12188111
• MDR Text Key: 262175611
• Report Number: 2521402-2021-00048
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367786
• UDI-Public: (01)04046964367786
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: SL-2010M2096
• Device Catalogue Number: SL-2010M2096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1