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

Model Number	4540008-02
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pain (1994)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility / translation of user facility information by bbm sales organization in (b)(6): "pump-air inlet." "week 51 during the day / 5 minutes after start of administration (primperan) with diffuser, chest pain.Emergency consultation - pulmonary embolism diagnosis - treatment administered - return home - nurses do a test on a diffuser without connection to the patient (primperan) - air bubble observation - the air filter is defective.".
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report (b)(4): the complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.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 Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report (b)(4): we received one used and empty easypump ii st 100-0,5-s without packaging and an original packed sample.The received samples were taken to a visual inspection.Damages were not detected at the received samples.In addition, the samples were filled up to the nominal value (100 ml) and was taken to a functional test respectively a leak test was carried out.After starting the pumps (opening the white clamp) and waiting for 60 minutes the pumps did work (solution was running).After these 60 minutes leakages were not detected.At the 2 samples we detected no leaks at the filter and furthermore we detected no leaks at the complete systems.Reviewed the dhr for batch 21f01ge382, there is no abnormality and no such defect detected at in process and at final control inspection.Based on customer description, they complained the filter is defective because they observed air bubles in the sample.For any bubbles that were formed at part before the filtered area, the air bubble will be removed after passing through the filter.It is potential that air bubbles observed by nurse is not due to filter malfunction but some preparation error such as incomplete priming.Since no filter leaking is observed and filter can function properly to prevent air from passing through it, thus this complaint is considered as not confirmed.
Event or Problem Description
As reported by the user facility / translation of user facility information by bbm sales organization in france: "pump-air inlet"."week 51 during the day / 5 minutes after start of administration (primperan) with diffuser, chest pain.Emergency consultation - pulmonary embolism diagnosis - treatment administered - return home - nurses do a test on a diffuser without connection to the patient (primperan) - air bubble observation - the air filter is defective.".

• Brand Name: EASYPUMP® II
• Common Device Name: ELASTOMERIC INFUSION PUMP
• 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, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13227193
• Report Number: 9610825-2022-00005
• Device Sequence Number: 4127964
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(17)250301(10)20C12GE221
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081905
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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 Model Number: 4540008-02
• Device Catalogue Number: 4540040
• Device Lot Number: 21F01GE382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown