MAUDE Adverse Event Report: B. BRAUN MEDICAL PRODUCTION LTD. EASYPUMP II LT 270-270-S; ELASTOMERIC INFUSION PUMP

Catalog Number 4540038

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/17/2014

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)): the pump was prepared for seven days but was finished after six days.

Manufacturer Narrative

(b)(4).A follow-up report will be provided after the inspection results are available.

• Brand Name: EASYPUMP II LT 270-270-S
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MEDICAL PRODUCTION LTD.; 300/32 moo 1 eastern seaboard ind. estate; tambon amphur, pluakdaeng, rayong 2114 0; TH 21140
• Manufacturer Contact: ludwig schuetz ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 3963684
• MDR Text Key: 4626119
• Report Number: 9610825-2014-00186
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/17/2014

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: 01/31/2017
• Device Catalogue Number: 4540038
• Device Lot Number: 2B1628ET12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2013
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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
• Patient Outcome(s): Other