MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EASY PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number 250/250

Device Problem Leak/Splash (1354)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

Bbraun easypump 250/250, lot: 22d5ge712, exp: 04/01/2027 leaked in the clean room while compounding for a patient.The product leaked where the tubing of the easypump connects to the "ball" of the product; 5 balls leaked and required us having to remix.These balls never made it to the patient.The incident was reported to the manufacturer.

• Brand Name: EASY PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16437474
• MDR Text Key: 310331439
• Report Number: MW5115165
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 250/250
• Device Catalogue Number: 4540048-02
• Device Lot Number: 22D25GE712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BED BALL X 5; MEROPENEM; SODIUM CHLORIDE ; STERILE WATER
• Patient Sex: Prefer Not To Disclose