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

Model Number SL-2000M2095D

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

As reported by the user facility: event 2 : detailed inquiry description: we have had 5 sets of lines break when stringing the machine.They are breaking at the arterial pod, prior to placing in blood pump.No patient involvement.

Manufacturer Narrative

(b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

Event 2: this report has been identified as b.Braun medical internal report number (b)(4).All information associated with this event was submitted to the bloodline manufacturer for further evaluation.Based on the evaluation results, three photographs of the tubing were provided and the tubing set was returned for product evaluation.Visual inspection of the photographs and returned sample confirmed the reported issue as the arterial line was broken where the pump segment connects to the pod.Although the reported defect was confirmed, the manufacturer was unable to determine a root cause of the reported defect.A search of the complaint database for this blood tubing set lot number shows no additional complaints of damaged components as of complaint closure, indicating this is an infrequent occurrence.Additionally, a review of manufacturing records for sl-2000m2095d lot 11155029 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: 15231980
• MDR Text Key: 305151846
• Report Number: 2521402-2022-00052
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046955348763
• UDI-Public: (01)04046955348763
• 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: 10/29/2022

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-2000M2095D
• Device Catalogue Number: SL-2000M2095D
• Device Lot Number: 11155029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 10/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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