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

Model Number 4540050-02

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Description

When compounding sterile iv products for a number of patients over the past few weeks, the bbraun elastomeric pump easypump® ii st gravity disposable 100ml capacity 100 ml volume 100 ml / hr have leaked.This is item ¿4540046-02.The pharmacist that is verifying the final compounded product has noticed the leaking on the majority of these affected doses and therefore that dose of medication is re-compounded prior to shipping to the patient.However, a few doses were shipped to patients---the patient called to let us know that the dose has leaked and that it is not sable.The dose appears to be leaking out right where the tubing exits the elastomeric device.When compounding for a particular patient, we will often times make them 7, 14, or 21 doses (depending in if they are infusing every 24, 12, or 8 hours) and only 1 or two of those doses are leaking, the rest are not.There are various lot numbers that we have noticed leaking: 22e29ge721 (1 leaked), 22h27ge723 (1 leaked), 22b17ge2r (we have had approximately 8 leaky doses between 5 patients.

• Brand Name: ELASTROMERIC PUMP EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16305499
• MDR Text Key: 309282816
• Report Number: MW5114708
• Device Sequence Number: 5
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4540050-02
• Device Catalogue Number: 4540050-02
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1