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

Catalog Number 4540016-02

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for evaluation and the investigation is on going at this time.A follow-up report will be provided when the inspection results become available.

Event Description

As reported by the user facility: event: no delivery of infusion.The product was filled with 96ml's of 5fu (chemotherapeutic drug) on (b)(6) 2016 and attached to client in clinic.When the client returned to clinic on (b)(6) 2016, all of the solution was still in the elastomeric.

Manufacturer Narrative

(b)(4).Statement from manufacturer: received one used and half filled easypump ii lt 100-50-s-us without packaging.The received sample was subjected to a visual examination.As received condition the white clamp was closed.The patient connector was closed with the original wing cap.After opening the top cap it was crystallized drug residues and residues of solution (liquid) was detected at the filling port and at the patient connector.Additionally, the sample was functionally tested for sixty minutes the pump worked (the solution was running).Leakage was not detected.Reviewed the device record and no abnormalities were found during the in process or final inspection.Based on the results of the investigation; no conclusions could be made regarding the cause of the event.If additional information becomes available, a follow-up will be submitted.

• Brand Name: EASYPUMP II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; mulsungen, 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5471785
• MDR Text Key: 39426309
• Report Number: 9610825-2016-00075
• Device Sequence Number: 1
• Product Code: MEB
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2016,02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: 4540016-02
• Device Lot Number: 14L21GE551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2016
• Distributor Facility Aware Date: 02/18/2016
• Event Location: Home
• Date Report to Manufacturer: 04/13/2016
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: No
• 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