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

Catalog Number 4540018

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Overdose (1988)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).Device history record (dhr):- reviewed the dhr for batch 19a07ge271, there is no abnormality and no such defect detected at in process and at final control inspection.No sample has been returned for investigation.Without the actual sample a thorough investigation can not be performed.All available information has been forwarded to the actual manufacturer.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in(b)(6)) : according to the customer:customer alleges that over 15% deviation is occurring in all lots of elastormeric pumps.They expect the infusion to be done in a certain period and mostly the infusion pump faster than expected.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 9938763
• MDR Text Key: 198695233
• Report Number: 9610825-2020-00086
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

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 Expiration Date: 01/01/2024
• Device Catalogue Number: 4540018
• Device Lot Number: 19A07GE271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1