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

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one unused easypump ii lt 270-27-s, a opened primary packaging and a picture from our customer.First, the received picture was taken to a visual inspection.By means of that picture an evaluation of the complaint is not possible.Further on, the unused sample and the opened primary packaging were taken to visual inspection.We received the following: one unused easypump ii lt 270-27-s, mat.-no.(b)(4), batch 14l15ge222.One opened primary packaging of easypump ii lt 100-50-s, mat.-no.(b)(4), batch 14l01ge261 if the customer received that unused sample (easypump ii lt 270-27-s, mat.-no.(b)(4), batch 14l15ge222) in this unopened original primary packaging (of easypump ii lt 100-50-s, mat.-no.(b)(4), batch 14l01ge261), we consider the complaint justified.The combination of received sample and received primary packaging is not in accordance with our requirements.We have informed our manufacturer accordingly.A follow-up report will be provided after the statement is available.A review of the batch and manufacturing records revealed no abnormalities or nonconformities.

Event Description

As reported by the user facility ((b)(4)): mix up: on the blister ref.4540016 batch 14l01ge261 (flow rate 2ml/h) inside eppii batch 14l15ge222 (volume 270 ml - flow rate 10 ml/h).

Manufacturer Narrative

(b)(4).Statement from manufacturer: define: received one piece of sample: unused m size pump of batch 14l15ge222 with 10 ml/hr flow rate sticker (green color).Opened original packaging of article 4540016 of batch 14l01ge261.Shop packet for batch 14l15ge222 is reviewed, it is confirmed that the product/batch belong to article 4540008 final assembly: back to back sequences during final assembly.The 'wrong' product 4540008 was produced just before the affected article 4540016.Packing: no back to back sequences.The 'wrong' product 4540008 of batch 14l15ge222 was not packed before or after article 4540016.Conclusion: corrective measures have been initiated and are documented under capa 001417 and capa 001432.Justification: 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: 4996729
• MDR Text Key: 22781225
• Report Number: 9610825-2015-00326
• 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
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 03/09/2016,07/29/2015

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: 09/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 4540016
• Device Lot Number: 14L01GE261
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2016
• Distributor Facility Aware Date: 07/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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