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

Catalog Number 4540016

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4) internal report#: (b)(4).Received 4 pieces of easypump ii lt 100-50-s without original packaging.The batch number on the big bottom cap of the 4 samples was 20a06ge261.Upon received, the outer shell of each of the samples was found to be attached with a medication label indicating those samples were used to be filled with ceftriaxone in nacl.The filling ports of those samples were closed with discofix caps.1st sample: no solution was found in the sample, and its clamp was opened.Its patient connector was closed with a valve connector.2nd and 3rd sample: no solution was found in the 2 samples, and its clamps were opened.Its patient connectors were closed with wing caps.4th sample: some brown solution was found in the sample, and its clamp was closed.Its patient connector was closed with a white combi stopper.Device history record (dhr): reviewed the dhr for batch 20a06ge261, and there was no abnormality, and no such defect detected at in process, and at final control inspection.Complaint and samples to be forwarded to production for further investigation.Note: this report is being filed for an item number that is not sold in the united states, however, this item or similar items are sold in the united sates by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): 48hrs infusion, early completed at 24hrs.Home patient reported at weekly review that first 3 pumps early completion.Supposed to infuse over 48hrs, but pumps emptied at 24hrs.4th pump was halted half way (24hrs) so can see balance solution remains.All these pumps filled with 96ml solution (ceftriaxone in saline).

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 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: 10488044
• MDR Text Key: 246652619
• Report Number: 9610825-2020-00201
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 09/03/2020

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 Catalogue Number: 4540016
• Device Lot Number: 20A06GE261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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