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

Model Number N/A

Device Problems Failure to Pump (1502); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is currently shipping from (b)(6) to bbm (b)(4) for investigation.A follow-up report will be provided when 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 (b)(6): there were problems with emptying the pump, the pump did not infuse the medication.After 46 hours of use the bag continued full and it was withdrawn.No problems were found with the catheter or precipitation of medication or clogging the pump.

Manufacturer Narrative

(b)(4).We received one used, empty easypump ii lt 100-50-s without packaging.The received sample was taken to a visual inspection.As-received condition the sample was soaking wet in the plastic bag.The white clamp was missing and the patient connector was not closed (the original wing cap was not handed over by the customer).Further on, we detected liquid and crystallized drug residues at the filling port (lli-cone) and at the patient connector (lla-cone).Damages were not detected at the sample.Additionally, the pump was filled with nacl 0.9 % up to the nominal volume (100 ml) and a functional test respectively a leak test was carried out (patient connector was closed with a blue combi stopper before filling the pump).After removing the blue combi stopper from the patient connector the pump did work immediately (solution was running).We detected no leakages at the sample within a test period of 60 minutes.Furthermore, the flow rate of the received sample was tested: nominal: 2 ml/h.Actual: 0.6 ml in 1 h; 1.5 ml in 2 hrs; 17.1 ml in 25 hrs.A slow flow (as described by the customer) could be detected at the sample.The received sample is not within our specifications.Hence we assess this complaint to be 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: 5405435
• MDR Text Key: 37725662
• Report Number: 9610825-2016-00017
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 08/09/2016,01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 4540016
• Device Lot Number: 14M08GE261
• 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: 08/09/2016
• Distributor Facility Aware Date: 01/08/2016
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2016
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2014
• 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