MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ULTRASITE®; SET, ADMINISTRATION, INTRA

Model Number	CSU100
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report # (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough sample analysis could not be performed and no specific conclusions could be drawn.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available, a follow-up report will be filed.Note: this case is being filed retrospectively as a result of a review of recent customer complaint information.Based on additional information and details provided in another complaint case, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of a similar nature in accordance with internal procedure (b)(4).
Event or Problem Description
As reported by the user facility: event # 1: reports the pump tubing unraveled from the ultrasite valve.The patient was scheduled for c6 folfox.The pharmacy prepared the 5fu continuous infusion dose in a c270050 iflow home pump c-series per the instructions of the manufacturer.The 5fu was prepared in the homepump c-series at 11:09 am on (b)(6) 2014.Volume of 5fu = 93.12 ml and volume of normal saline = 136.88 ml.Total volume in the pump = 230 ml.The treating nurse was attaching the pump to the patient at 3:45pm.The nurse attached the luer lock connector of the homepump to the ultrasite access device.The luer lock connector immediately started to turn back off of the ultrasite injection site and disconnect.The pharmacy prepared another dose in a new iflow homepump c-series elastomerc pump at 4:25pm.The nurse tried to connect at 4:30pm and the same incident occurred again.The pharmacy then prepared a third dose at 4:35pm.This time the pharmacy placed the ultrasite injection site onto the luer lock connector of the elastomeric pump during compounding.The nurse attached it to the patient at 4:45pm.The connection remained.Nursing was able to attach and then taped the connection.

• Brand Name: ULTRASITE®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6112810
• Report Number: 2523676-2016-00730
• Device Sequence Number: 19113441
• Product Code: FPA
• UDI-Device Identifier: 04022495769923
• UDI-Public: (01)04022495769923(17)180430(10)0061313090
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K031923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/08/2014

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
• Operator of Device: Nurse
• Device Expiration Date: 04/30/2018
• Device Model Number: CSU100
• Device Catalogue Number: 415110
• Device Lot Number: 0061313090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2014
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C270050 IFLOW HOME PUMP C-SERIES
• Patient Age: 50 YR