MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Air/Gas in Device (4062)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

As reported by the user facility: this rn was to administer a prbc transfusion for a pt.Pt is known to have antibodies, and there was difficulty finding a compatible unit of prbcs for her.Blood was delivered in a timely manner from blood bank via the tube station.Rn to bedside immediately after obtaining prbcs.Multiple delays in administration occurred, such as unexpected pre-medications and piv infiltration.However, the biggest delay occurred with the iv pump and tubing malfunctioning.Rn had to trouble shoot for 30 minutes due to the pump continuously alarming that air was in line.Multiple interventions attempted to fix the issue such as: having the pump re-prime itself several times, flipping the pump vertically, restarting the pump, exchanging the pump.Finally the tubing was exchanged which finally appeared to fix the issue and allowed the blood transfusion to initiate.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.Because a lot number was not provided it is not possible to determine if this device met the specifications that applied at the time it was manufactured.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.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• 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: 19134557
• MDR Text Key: 341459879
• Report Number: 2523676-2024-00358
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/18/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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