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

Model Number N/A

Device Problems Partial Blockage (1065); Pumping Problem (3016)

Patient Problem No Information (3190)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up report will be provided after the inspection results are available.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): pump-damaged-blocked.

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.

• 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: 5875920
• MDR Text Key: 53038200
• Report Number: 9610825-2016-00551
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2016,07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4540016
• Device Lot Number: 15E28GE261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2016
• Distributor Facility Aware Date: 07/18/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2016
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2015
• 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