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

Catalog Number 4540032

Device Problems Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4) internal report # (b)(4).We received one used and empty easypump ii lt 270-135-s without packaging.The returned sample was taken to a visual inspection.Damages or manufacturing faults were not detected at the received sample.As-received condition the white clamp and the patient connector were closed (combi-stopper), the original wing cap was not handed over by the customer.After opening the big top cap and removing the closing cap, we detected solution at the filling port (lli-cone) of the sample.In addition, the sample was filled up with 270 ml nacl 0.9% and was taken to a functional test respectively a leak test was carried out.After opening the patient connector and the white clamp, the pump was working properly (solution was running).We detected a leakage at the filter, the solution was running out of the filter housing.Due to the current covid-19 situation, sample is stored at bbm and not forwarded to manufacturing site.Reviewed the device history record for batch 19h28ge341, there is no abnormality and no such defect detected at in process and at final control inspection.Summary of root cause analysis: in this case, only bbm had received the sample for investigation and based on their investigation, they found that there is leaking at filter area.Due to leaking at filter, the flow rate of the sample cannot be determined.Regarding the leakage we have informed our manufacturing department accordingly.A follow-up report will be provided after the statement is available.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)(6)): therapy with fu was adjusted, because too much has been started in too short a time.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).No or new pertinent information is available for this complaint.The claimed defect according to flow rate deviation could not be tested, since the sample was leaking at the filter area.The defect about the leakage at the filter area was already addressed.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 10488041
• MDR Text Key: 231469379
• Report Number: 9610825-2020-00200
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4540032
• Device Lot Number: 19H28GE341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1