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

Model Number SL-2010M2096

Device Problem Air/Gas in Device (4062)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

As reported by the user facility: event 11: "hospital clinical coordinator has noted that there are major kinks on the lines, one set had a small crack and ended up having air in pt's blood, unable to return blood.Some had the saline going to the venous tranducer line causing strike-through.Saline going up to transducer connector in the machine.If saline was going to the transducer connector, blood could also go there, causing what we call strike through.To my knowledge no harm was caused to the pt, and we had a minimal blood loss.".

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.

Manufacturer Narrative

Event 11: this report has been identified as b.Braun medical internal report number (b)(4).No sample or photo were submitted to the manufacturer for evaluation.Further investigation of the complaint is not possible.The actual defective device is a valuable tool in investigating the cause of this incident.While the complaint is not 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.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: 15964419
• MDR Text Key: 307887532
• Report Number: 2521402-2022-00156
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2010M2096
• Device Catalogue Number: SL-2010M2096
• Device Lot Number: A2200551
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• 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