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

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received 1 used easypump in open package.The received sample and the primary package were visually examined.Nominal: easypump ii lt 60-30-s (volume: 60 ml and flow rate: 2 ml/h).Actual - sample: easypump (volume: 100 ml and flow rate: 200 ml/h with batch: 14m29ge381).Actual - primary package: easypump ii lt 60-30-s (volume: 60 ml and flow rate: 2 ml/h with batch: 14m19ge231).The product inside the primary package is not according to the outer label of the primary package.We have informed our manufacturer accordingly.Statement: based on the photos received, the actual article number on the primary package was easympump ii lt 60-30-s with batch number 14m19ge231.However, the actual product inside the primary package was found to be easypump ii st 100-0.5-s with batch number 14m29ge381.No other deviation is observed at the complaint sample.Analysis: mixed up issue between both articles 4540010 and 4540040 of easypump.Complaint batch of 14m19ge231 (article 4540010) was packed directly after batch 14m29ge381 (which is actually article 4540040) on the same day, dated 2014-12-05.One piece of article 4540040 was mixed up and packed accidentally into article 4540010 packing process.Potential root cause identified: line clearance was not performed sufficiently between article 4540010 (14m19ge231) and 4540040 (14m29ge381).Line clearance checklists for both articles at grey and white area were checked.Observed that line clearance has been done accordingly based on the tracking form.Error in production quantity reconciliation.The shop packet quantity was checked for article 4540010 (14m19ge231) and 4540040 (14m29ge381).Production quantity reconciliation error caused one of the article 4540040 pumps to be packed during the packing process of article 4540010 pump.Conclusion: the easypump product inside primary package is not accordance to the outer article label of primary package.(b)(4).Corrective measures have been initiated and are documented under capa(b)(4).Justification: justified.Reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by the user facility ((b)(4)): on the filter, the yellow sticker is inscribed "200 ml/h" instead of "2 ml/h".The nurse saw it during the filling so the easypump has not been connected to the patient.

• 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: 5230179
• MDR Text Key: 31395755
• Report Number: 9610825-2015-00537
• 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: Initial
• Report Date: 11/17/2015,04/21/2015

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: Nurse
• Device Expiration Date: 10/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 4540010V
• Device Lot Number: 14M19GE231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Distributor Facility Aware Date: 11/11/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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