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

Model Number N/A

Device Problems Failure to Deliver (2338); Application Program Problem: Medication Error (3198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used, (empty) easypump ii lt 100-50-s without packaging.The received sample was taken to a visual inspection.In as-received condition the white clamp was missing and the patient connector was not closed; we received the sample soaking wet in the plastic bag.The original wing cap was not handed over by the customer.After opening the top cap and removing the closing cone, we detected solution (liquid) and crystallized drug residues at the filling port (lli-cone).Further on, we detected residues of the solution (liquid) respectively crystallized drug residues at the lla-cone of the patient connector.In addition, a functional test respectively a leak test was carried out.After waiting for a while the pump did work (solution was running).Leakages were not detected at the sample.A blocked sample (as described by the customer) could not be determined.The tested sample is in accordance with our requirements.We have informed our manufacturer accordingly.A follow-up report will be provided after the statement is available.Reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): the customer complains that in a short time 3 pumps did not perfused, i.E., they remained filled until the patient returns to hospital again.These pumps contained 5-fu and consequently patients did not do the full chemotherapy cycle.

Manufacturer Narrative

(b)(4).B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun (b)(4).This report has been identified as b.Braun melsungen ag internal report # (b)(4).No additional pertinent information has become available.We assess this complaint to be not justified.

• Brand Name: EASYPUMP® II
• Type of Device: 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: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5230116
• MDR Text Key: 31672912
• Report Number: 9610825-2015-00549
• Device Sequence Number: 1
• Product Code: MEB
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2016,10/28/2015

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: 01/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4540016
• Device Lot Number: 15B26GE261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2016
• Distributor Facility Aware Date: 10/28/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2016
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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