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

Model Number 4540018-02

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

As reported by the user facility: detailed inquiry description: it looks like the plastic parts on the current 5fu pumps have shown up cracked/cracked while compounding.Unable to give medication due to pump leaking during infusion and set up.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).Sample/s evaluation: bmi received 3 pieces of easypump ii lt 270-54-s-us, one damaged sample and two reference samples from the customer.Complaint and reference samples were labeled respectively.Refer to table 1 for sample evaluation results.Table 1: sample evaluation results.Damaged sample.Reference sample 1 reference sample 2.Observation: as received condition, damaged sample was not clamped whereas the two reference samples were still in original packaging and not clamped as well.Measure: refer to manufacturing sop of elastomeric infusion system: hc-my01-m-5-4-16-002-0, hc-my01-m-5-4-16-012-0, hc-my01-m-5-4-16-015-0, hc-my01-m-5-4-16-044-0.Analysis: according to the customer's descriptions, crack at filling port and leakage were observed during infusion/compounding while using equashield syringe.Filling port of the samples were taken to visual inspection for damages.Refer to table 2 for the filling port investigation results.Table 2: filling port investigation results.Damaged sample reference sample 1 reference sample 2.Observation: the filling port of the damaged sample was found to be broken off and the btc was removed and not returned by the customer.No abnormality was observed on the filling port of reference samples after removing the discofix cap.To further analyze on the root cause of leakage, the reference samples were filled with equashield syringe and adapter.The equashield adapter was able to fit properly to the filling port, then proceeded to filling process for both reference samples to their nominal volume.Refer to figure 1 to 3.Leakage test was not able to conduct on the damaged sample as the filling port was broke.Refer to table 3 for pump leakage investigation results.Table 3: pump leakage investigation results.Reference sample 1 reference sample 2.Observation: no leakage was further observed from filling port, valve area, silicone sleeve, filter and tube connection.No abrnomality nor crack was observed on the filling port after btc was removed.In response to the damaged sample, further information was requested regarding how the customer was able to reproduce the issue, which resulted in broken filling port and btc detach.Based on the below email communication, it is clear that the defect was reproduced intentionally by customer to illustrate the defect.The broken filling port is not due to failure in production process.Summary of root cause analysis: bmi received two reference samples with no abnormality and one damaged sample with broken filling port and without btc.The broken piece of cap valve and btc was not returned, further visual inspection on the other part of cap valve was unable to be conducted.The defect on the damaged sample was recreated by customer and not due to failure in production process.No abnormality was observed from the reference sample after filling with equashiled syringe and adapter.Hence, this complaint is not confirmed.Cause : cause could not be determined.Neither defect nor abnormality was detected on the received samples.Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: not applicable.Justification: not confirmed.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERI
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17214098
• MDR Text Key: 318146674
• Report Number: 9610825-2023-00299
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4540018-02
• Device Catalogue Number: 4540018-02
• Device Lot Number: 23A26GE561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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