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

Model Number N/A

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested to be sent for investigation at our bbm laboratory in (b)(4).A follow-up report will be provided after the examination results are available.

Event Description

As reported by the user facility ((b)(4)): slow flow // underinfusion.Underfused - did not start at all - patient rang nurse to come back after a couple hours.

Manufacturer Narrative

(b)(4).Sample evaluation: received one and filled with yellowish brownish solution easypump ii lt 270-27-s (batch no.Labeled 14l15ge22r/material no.4540008 on the big bottom cap of the sample) without original packaging.Examined the returned sample visually.Clamp clip was clamped.Patient connectors was not closed with the original closing cone (wing cap).Fill port cap (discofix) was in position.The complaint sample were unclamped and waited for 30 minutes and observed the pump was not working (solution was not running).Damages and cracks and leakages was not detected upon visual inspection at the distance of 25cm.Furthermore, the sample was subjected to leakage test.No leaking was detected.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.However, slow flow rate issue is a known error pattern and corrective and preventive actions are in progress / have been implemented.

• 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: 5730706
• MDR Text Key: 47597189
• Report Number: 9610825-2016-00367
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2016,06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4540008
• Device Lot Number: UNKOWN
• 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: 08/22/2016
• Distributor Facility Aware Date: 06/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2016
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: No
• 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