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

Model Number N/A

Device Problem Failure to Pump (1502)

Patient Problem No Information (3190)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is currently shipping from (b)(4) to bbm in (b)(4) for investigation.A follow-up report will be provided after the inspection results are 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)): no flow.Drug: fortum antibiotic the patient explains that the pump she had last night for his fortum did not infused.However, she explains that nurse came this morning; she looked and the pump infused again.Do not know if the tubing was bent and if the stopcock was turned the wrong way.

• 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: 5201778
• MDR Text Key: 30702812
• Report Number: 9610825-2015-00507
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2015,10/12/2015

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: 12/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 4540040
• Device Lot Number: 15A29GE381
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2015
• Distributor Facility Aware Date: 10/12/2015
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2015
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2015
• 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