MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG EASYPUMP 2; ELASTOMERIC PUMPS

Catalog Number	4540008-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Vomiting (2144)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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 or Problem Description
According to the event description: in a hospital, nursing staff used an easy pump lt270-27 diffuser, braun reference (b)(4), batch 24d20ged41 on a patient.The diffuser was filled with 5 fluorouracyl for a quantity of 1750mg (milligrams) (35 ml (milliliters)), diluted in nacl 0.9% (vol 192ml).The infusion was initiated on (b)(6) 2024 at 5pm.On (b)(6) 2024 at 8:30am, the nursing staff noticed that the diffuser was empty.The infusion therefore lasted 15 hours 30 minutes instead of the expected 22 hours.The diffuser infused much faster than expected.The patient was more prone to nausea than during the previous treatment.The diffuser is in quarantine at the customer's facility.We are due to collect it on wednesday (b)(6) 2024.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).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.Additional information: d9 device returned to manufacturer device history record (dhr): reviewed the dhr for batch 24d20ged41, there was no defect encountered during in process and final control inspection.Sample evaluation: received one sample of easypump ii lt 270-27-s-eu/sa without original packaging.The batch number on the big bottom cap of the sample was 24d20ged41.Upon received, no solution was observed in the sample and the sample was clamped.A medication label attached on the outer shell of the sample indicates that the sample was used to be filled with fluorouracil.Its filling port was closed with a discofix cap, whereas its patient connector was closed with a connector.Investigation results: the flow rate report of affected batch 24d20ged41 was reviewed.For final control flow rate (after eto) report, the average flow rate deviation from the nominal flow rate was between 3.11% and 9.61%.The received sample was weighed and recorded at 81.69.An unfilled easypump for this article typically weighs 75g, and the retained volume should be [?]3g.This indicates that the remaining solution at received sample was around 3g.Visual inspection had done throughout the received sample.White crystallized residue was found at the filling port and filter of received sample.The sample was sent for decontamination for flow rate test.However, the received sample was unable to be decontaminated as the sample was blocked.The white precipitation was not able to be flushed out.Since the received sample was blocked, further investigation for flow rate was not possible.White crystallize was observed at the received sample.The blockage of the received sample was due to white crystallize observed at the flow restrictor.The crystallization / precipitation of drug will affect the flow rate of the sample.The crystallization/ precipitation will cause the blockage on the path of the solution.There are some drugs (e.G.5fu, cefepime) which tend to crystallize / precipitation at some special conditions.The risk of crystallization is given by the drug itself and may affect some functions of the pump (filter, microbore, glass tube).However, there are some possibilities that can cause fast flow rate to occur during application, such that one or combination factors are listed as below: 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 approximately by 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 approximately 18% which means the flow rate will increase from 10 ml/hr to 11.8 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 than the nominal time.Simulation of external pressure had been conducted.The flow rate of the product can increase when external force is applied to the pump.However, this external force is against the intended use of the product according to ifu.Factor 3: folded outed shell according to ifu, the outer layer has to be unfolded properly prior filling.Folded outer shell will act as the external pressure to elastomeric membrane and increase the flow rate of the product.Conclusion: since the received sample is blocked, further investigation for flow rate was not possible, hence, we considered this complaint as not confirmed.The blockage of the received sample was due to white crystallization observed at the flow restrictor.

• Brand Name: EASYPUMP 2
• Common Device Name: ELASTOMERIC PUMPS
• 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20603750
• Report Number: 9610825-2024-00788
• Device Sequence Number: 7346341
• Product Code: MEB
• UDI-Device Identifier: 04046964448461
• UDI-Public: (01)04046964448461(17)290401(10)24D20GED41
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4540008-07
• Device Lot Number: 24D20GED41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown