MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASY PUMP 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 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample involved has been received for evaluation and the investigation is ongoing at this time.A follow up report will be submitted when the investigation results become available.

Event Description

As reported by the user facility: event 1.While infusing the drug fluoruracil cl (5 fu cl) the customer reported that the easy pump did not deliver the treatment to the patient.No patient injury.

Manufacturer Narrative

(b)(4).We received 2 used easypump ii lt 100-50-s-us without packaging.The received samples were taken to a visual inspection.As-received condition: sample 1: the sample was half filled.The white clamp is closed and the patient connector was not closed (the original wing cap was not handed over by the customer).After opening the top cap and removing of the closing cone we detected solution at the filling port (lli-cone) and at the patient connector (lla-cone).Sample 2: the sample was empty.The white clamp is closed and the patient connector was not closed (the original wing cap was not handed over by the customer).After opening the top cap and removing of the closing cone we detected solution at the filling port (lli-cone) and at the patient connector (lla-cone).In addition the samples were filled up to the nominal value (100 ml) and were taken to a functional test respectively leak test.Sample 1: after starting the pump and waiting for 60 minutes the pump did work (solution was running).After these 60 minutes leakages were not detected.Sample 2: after starting the pump and waiting for 60 minutes the pump did not work (solution was not running).After these 60 minutes leakages were detected.A leakage was detected at the filter, the solution runs out of the ventilation hole of the filter.One inspected sample is not within our specifications.Reviewed the device history record and no abnormalities found during in process and final control inspection.

• Brand Name: EASY PUMP II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5540648
• MDR Text Key: 41618759
• Report Number: 9610825-2016-00154
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2016,03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 4540016-02
• Device Lot Number: 14K05GE551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2016
• Distributor Facility Aware Date: 03/16/2016
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2016
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1