MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. B BRAUN INFUSOMAT SPACE PUMP IV SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 0061847174

Device Problems Defective Device (2588); Air/Gas in Device (4062)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

Over the last few days, a cath lab nurse reported going through at least 10 bbraun infusomat spacepump iv sets as it caused tons of bubbles and air-in-line alarms in the bbraun pumps.Due to this observation and they decided to proceed with a different lot number which caused no further issues down the road.Fda safety report id# (b)(4).

• Brand Name: B BRAUN INFUSOMAT SPACE PUMP IV SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 15761074
• MDR Text Key: 303422254
• Report Number: MW5113183
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/04/2022
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

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 Lot Number: 0061847174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1