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 03/14/2024

Event Type  malfunction  

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.

Event Description

As reported by the user facility: brief inquiry description: medication pump consistently alarming on patient in ticu/burn icu.As reported by the user facility: brief inquiry description: medication pump consistently alarming on patient in ticu/burn icu.Detailed inquiry description.Good afternoon, i hope this letter finds you well.I am writing to bring your attention, once again, to a critical issue regarding the medication pumps currently in use at our facility.As a dedicated nurse, i have observed firsthand the impact of these alarms on our workflow, patient care, and overall well-being of the patient and nurses.I attended the meeting with the braun representative and was able to give some feedback from a bedside nurse perspective.Since the meeting, i have written several incident reports, saved the tubing and returned the pumps as i was instructed to do.While we are waiting for "research" to be completed, the pumps continue to alarm and the frustration continues to overwhelm nurses but most importantly, continues to interfere with patient treatment and care.Thus, the reason for this email.Over the past three two days, the medication pumps associated with my patient's abdominal drains have been persistently alarming due to air bubbles.This alarming frequency has significantly disrupted nursing workflow and compromising patient safety.My patient's condition necessitates continuous irrigation through multiple abdominal drains.This therapy is crucial for reducing tissue edema, enhancing blood flow, preventing organ ischemia, and minimizing cellular hypoxia.The constant interruption due to air bubbles is delaying treatment, compromising the patient's recovery, increasing the probability of infection, prolonging hospitalization and decreasing overall patient/family satisfaction.Another issue is the constant alarms divert our attention away from other critical tasks, hindering our ability to provide efficient care to all patients.The repetitive alarms contribute to alarm fatigue among nursing staff, making it challenging to differentiate urgent alerts from routine notifications.In an effort to resolve the issue, i have diligently performed the following steps: checked the patency of the drain, flushed the drain, increased the rate of irrigation; decreased the rate of irrigation, lowered the suction; increased the suction, changed the tubing, lifted the tubing from the bag to the pump, lifted the tubing from the pump to the patient, flicked the tube, raised the pole, primed the tubing using the pump, primed the tubing by gravity, removed the tubing and reprimed flicking the tubing to move any bubbles, (visible and nonvisible) repositioned patient.Repeated these steps several times through the shift for three days in ticu room a there were 50 pumps, 48 in use.Two pumps were set up for backup for a patient requiring dobutamine and norepinephrine despite these efforts, the problem persists, and the patient continues to experience unnecessary delays in receiving essential care.My pump care prioritized patient care.No injury reported.

• 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: 18985190
• MDR Text Key: 338675633
• Report Number: 2523676-2024-00296
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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
• Date Manufacturer Received: 03/14/2024
• 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