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

Model Number SL-2000M2095

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

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: a hemodialysis (hd) patient had a blood leak from the bloodlines during treatment.The leak occurred immediately into the patient's treatment.The primary care technician (pct) could see blood dripping out of the arterial line and bulb connection onto the floor once the flow speed was increased.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation is ongoing at this time.This follow up is being submitted as additional information was received.Sections b5, e1 and h6 have been updated.A follow up will be submitted when the investigation results become available.

Event Description

As reported by user facility: a hemodialysis (hd) patient had a blood leak from the bloodlines during treatment.The leak occurred immediately into the patient's treatment.The primary care technician (pct) could see blood dripping out of the arterial line and bulb connection onto the floor once the flow speed was increased.No injuries were reported.Additional information received: patient lost an estimated 180-200 ml of blood and lost 20 minutes of treatment time.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).All information associated with this event was submitted to the bloodline manufacturer.According to the manufacturer investigation, the blood tubing set was returned for evaluation, however the sample received date was not provided.The complaint was confirmed as a leak was noted where the pod connected to the pump segment.Photographs of the blood tubing set were taken and provided for 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-2000m2095 from lot 10255030 was performed and indicated that there were no quality issues during the manufacturing process of this lot related to the reported issue.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: 12646307
• MDR Text Key: 276840015
• Report Number: 2521402-2021-00071
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367762
• UDI-Public: (01)04046964367762
• 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,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2024
• Device Model Number: SL-2000M2095
• Device Catalogue Number: SL-2000M2095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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