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

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

(b)(4): the sticker on the filter is "250 ml/h" instead of "2 ml/h".

Manufacturer Narrative

(b)(4).The device is currently shipping from (b)(6) to bbm in (b)(4) for investigation.A follow-up report will be provided when the inspection results are available.We have informed our manufacturer accordingly.Reviewed the device history record and no abnormalities found during in process or final control inspection.

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.Without the actual sample , a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.

• 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: 4928842
• MDR Text Key: 6433947
• Report Number: 9610825-2015-00244
• 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,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2015,06/24/2015

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: 11/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 4540010
• Device Lot Number: 14N18GE231
• Other Device ID Number: N/A
• 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: 10/21/2015
• Distributor Facility Aware Date: 06/24/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2015
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 07/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• 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