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

Model Number 4540010-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Inadequate Pain Relief (2388)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4) internal report (b)(4), event 2: the complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.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): event 2 "overinfusion"."the client encountered a problem in 2 of their patients for whom they installed 24-hour diffusers for the administration of analgesics.Indeed, the product was delivered too quickly, for a duration according to the statements of the patients of 8h, 9h and 12h instead of the expected 24 hours.The patient did not received him treatment during the expected duration so he was not relieved of his pain as he should the medication has been administrated per os when the defect has been detected.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4), event 2.As no sample and no meaningful picture was provided, proper investigation on malfunction could not be performed.Hence, the complaint is considered as not confirmed.Device history record (dhr): reviewed the dhr for batch 21d07ge231, there is no abnormality and no such defect detected at in process and at final control inspection.

• Brand Name: EASYPUMP® II
• Type of Device: ELASTOMERIC INFUSION PUMP
• 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 18109 ; 4847197287
• MDR Report Key: 12728105
• MDR Text Key: 279309113
• Report Number: 9610825-2021-00453
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448515
• UDI-Public: (01)04046964448515(17)260401(10)21D07GE231
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

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 Model Number: 4540010-02
• Device Catalogue Number: 4540010
• Device Lot Number: 21D07GE231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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