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

Catalog Number 4540016

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)): there was no infusion.

Manufacturer Narrative

(b)(4).We rec'd one used and half filled easypump ii lt 100-50-s without packaging.The rec'd sample was taken to a visual examination.Damages were not detected on the sample.In 'as-rec'd' condition, the white clamp was missed on the sample.The original wing cap was not handed over by the customer; the pt connector was closed.After opening the top cap and removing the closing cone, we detected solution (liquid) and crystallized drug residues at the filling port (lli-cone).Furthermore we detected no solution (liquid) or crystallized drug residues at the lla-cone of the pt connector.Additionally the sample was filled up to the nominal value (110 ml) and a functional test, respectively a leak test, was performed.After waiting for a while the pump did not work (solution was not running).Despite squeezing the pump by hand, the pump did not work (solution was not running).Leaks at the pump were not detected.The sample is not within our spec.A f/u report will be provided as soon as the statement from mfr is available.(b)(4).

• 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: 4586480
• MDR Text Key: 5448952
• Report Number: 9610825-2015-00060
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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
• Report Date: 03/06/2015,01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Catalogue Number: 4540016
• Device Lot Number: 14G10GE261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2015
• Distributor Facility Aware Date: 03/02/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2015
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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