MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE DUO-VENT SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	ACT5435
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the reported condition was the user error attempting to use an interlink system secondary medication set (2c7451) and solution set with duo-vent spike (act5435) together.The two devices are not compatible with each other as the act5435 has a needle based y-site and the 2c7451 uses a male luer at the end of the set.Proper user instructions are addressed in the labeling for an interlink system secondary medication set, which is shipped with the device.The label warns the user that the secondary medication set interlink system is for use with interlink system continu-flo solution sets.The label also includes instruction for use which state to insert the cannula into an interlink y-injection site on continu-flo set.Proper user instructions are addressed in the labeling for a solution set with duo-vent spike (act5435), which is shipped with the device.The label includes instruction for use which state to access the injection site with siliconized 18 gauge (or smaller bore) needle.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an interlink secondary medication set would not connect to the access port of a solution set.During setup, the customer was unable to puncture the port of the primary solution set with the secondary set.This event occurred during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: DUO-VENT SOLUTION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• MDR Report Key: 7355611
• Report Number: 1416980-2018-01481
• Device Sequence Number: 1172777
• Product Code: FPA
• UDI-Device Identifier: 00085412079684
• UDI-Public: (01)00085412079684
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: ACT5435
• Device Lot Number: SR17B16105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1