MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG B BRAUN ELASTOMERIC INFUSION PUMP EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Device Problem Infusion or Flow Problem (2964)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 09/06/2022

Event Type  Injury  

Event Description

Aki due to vancomycin infusion.Fda safety report id# (b)(4).

• Brand Name: B BRAUN ELASTOMERIC INFUSION PUMP EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 15596670
• MDR Text Key: 301848082
• Report Number: MW5112596
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VANCOMYCIN: (B)(6) 2022-(B)(6) 2022
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White