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

Model Number N/A

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used, empty easypump ii lt 125-25-s without packaging.The provided sample was subjected to a visual inspection.Damages or manufacturing faults were not detected.As-received condition the clamp clip was closed.The patient connector was not closed, the original wing cap was not handed over from the customer.Further on, we detected crystallized drug residues and solution at the filling port (lli-cone) of the sample.Additionally, the pump was filled with nacl 0.9 % up to the nominal volume (125 ml) and a functional test respectively.A leak test was carried out.After opening the clamp clip and starting the pump the pump did work immediately (solution was running).Leakages were not detected at the sample.Flow rate test: nominal: 5 ml/h.Actual: 7.1 ml in 1 h; 12.3 ml in 2 hrs; 65.9 ml in 16 hrs.A fast flow (as described by the customer) could not be determined at the received sample.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.All available information has been forwarded to the actual manufacturer.If additional pertinent information becomes available, a follow up report will be filed.

Event Description

As reported by the user facility ((b)(4)): fast flow - the pump emptied too fast.

• 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: 6041910
• MDR Text Key: 57930206
• Report Number: 9610825-2016-00666
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2016,09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540006
• Device Lot Number: 16C04GE211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2016
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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