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

Catalog Number 4540006

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)): easypump does not flow.Happened in oncologist ambulance, pump was filled with 5-fu.Planned application could not be conducted.Application was conducted later with another application sys.

Manufacturer Narrative

(b)(4).The device is currently shipping from the customer to (b)(4) for investigation.A f/u report will be provided when the inspection results became available.(b)(4).

Manufacturer Narrative

(b)(4).We received one used, approx.Half filled easypump ii lt (b)(4) without packaging.The received sample was visually inspected.Damages were not detected.In as-received condition, the white clamp was closed.The original wing cap was not handed over by the customer, the patient connector was closed with a red combi stopper.After opening the top cap and opening the closing cone, we detected liquid at the filling port (lli-cone) and at the lla-cone of the patient connector.The sample was filled to the nominal value (125 ml) and a functional test was carried out.After opening the white clamp and waiting for a while the pump worked (solution was running).Furthermore, we tested the flow rate of the received sample.Nominal: 5 ml/h.Actual: 6.9 ml in 1 h; 13.4 ml in 2 hrs; 19.0 ml in 3 hrs.During the test of the flow rate we did not detected any leaks at the sample.A blocked sample was not detected during the test of the flow rate.The inspected sample is within our specifications.Hence we assess this complaint to be not justified.We have informed our manufacturer accordingly.Reviewed the device history record (dhr) and no abnormalities found during in process and final control inspection.

• Brand Name: EASYPUMP II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4586502
• MDR Text Key: 5482505
• Report Number: 9610825-2015-00062
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2015,02/18/2015

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: 09/01/2019
• Device Catalogue Number: 4540006
• Device Lot Number: 14K18GE211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2015
• Distributor Facility Aware Date: 03/02/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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