MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INFUSOMAT SPACE PUMP IV SET PRIMARY TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 0061834647

Device Problems Crack (1135); Leak/Splash (1354); Air/Gas in Device (4062)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2022

Event Type  Injury  

Event Description

Iv tubing cracked resulting in loss of medication, air in the line on the patient side, potential for infection.On (b)(6) 2022 and (b)(6) 2022 (three total sets found).We have sent one set back to the manufacturer and retained one set.Fda safety report id# (b)(4).

• Brand Name: INFUSOMAT SPACE PUMP IV SET PRIMARY TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 15174464
• MDR Text Key: 297463578
• Report Number: MW5111288
• Device Sequence Number: 2
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/02/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 0061834647
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention