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

Catalog Number 4540032

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).We received one used easypump ii lt 270-135-s without packaging.The received sample was taken to a visual examination.As-received condition the patient connector was closed with a closing cone.After opening the big top cap and removing the closing cap, we detected no solution at the filling port (lli-cone).Damages that would lead to a malfunction were not detected at the sample.In addition the sample was taken to a functional test respectively a leak test was carried out.Therefore the pump was filled up to the nominal volume of 270 ml with nacl 0.9 %.After starting the pump (opening the white closing cone) and waiting for 60 minutes the pump was not working (solution was not running).Leakages were not detected.The pump has been forwarded to the manufacturing site for additional evaluation.A follow-up report will be provided after the statement is available.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): the drug was finished early the pump was prepared for four days but the drug was finished after one day.

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: 18e29ge34r, which was a reworked batch for 18e29ge341 with holdback at final control inspection due to slow flow rate.Rework was performed on that batch.After reworked, the batch was tested as per test specification and passed all tests, thus the batch was released.Summary and assessment: we detected after 60 minutes the received pump is blocked.Because the sample is blocked a too fast flow (as described by the customer) could not be determined at the received sample.We have informed our manufacturing department accordingly and received the statement as follows: dissection was performed on the received sample to verify the blockage point.After the glass tube was cut off, the solution started to flow out.Therefore, it is indeed the crystallized residue at glass tube that blocked the flow.The flow restrictor was blocked by the crystallized drug residue, flow rate testing was not able to be performed on the received sample due to the blockage at the glass tube lumen.The flow restrictor of the received sample were removed and the inner diameter of the tubing (microbore tube) was measured under smartscope.The tube id is within the specification.Then, a new flow restrictor was assembled to the received sample and sent for flow rate test.The flow rate result was within specification ± 15% deviation from nominal flow rate.The blockage observed during bmi investigation was contributed by the crystalized drug residue in the glass tube lumen of the flow restrictor.Flow rate was within specification after the received pump assembled to a new flow restrictor.The crystallization of drug will affect the flow rate of the sample.The crystallization of drug will cause blockage or partial blockage on the path of solution.Hence, the flow of the solution will become slower.There is some drugs (e.G.5fu) which tend to crystallize at some special condition.The risk of crystallization is given by the drug itself.Some function of pump (filter, microbore, glass tube) may affected when forming high amount of crystallize particle from drug.The blockage issue due to cytotoxic drug has been addressed in capa.However, there are some possibilities that can cause the sample to empty the solution earlier, which is before the nominal time.Factor 1 temperature: the temperature of the surrounding will affect the flow rate of the sample.For every increase of 1°c, the flow rate of the sample will increase by approximately 3%.For example, if the flow restrictor of the product reaches the temperature of 37°c, the flow rate of the sample will increase by approximate 18%, which mean the flow rate will increase from 2 ml/hr to approximately 2.36 ml/hr.Factor 2 external pressure: external pressure such as squeezing or laying on the pump will increase the flow rate which cause the pump to empty earlier, before the nominal time.Simulation of external pressure had been conducted.The flow rate of the product can increase when external force is applied on the pump.However, this external force is against the intended use according to ifu.Factor 3 folded blow mold: folded blow mold will also act as the external pressure to elastomeric membrane and increased the flow rate of the sample.Summary of root cause analysis: complaint on flow rate could not be confirmed due to the blockage at the glass tube.However, the flow rate test on the received sample after replacing of new flow restrictor showed the flow rate result within the specification.The id of the microbore tube of the original flow restrictor from received sample showed the id measurement within specification.Flow contribution by the flow restrictor from received sample was not able to be confirmed.

• 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: 9583313
• MDR Text Key: 198607763
• Report Number: 9610825-2019-00564
• 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: 03/30/2021

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 Expiration Date: 05/01/2023
• Device Catalogue Number: 4540032
• Device Lot Number: 18E29GE34R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1