MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO INTERLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C6671
Medical Device Problem Code	Reflux within Device (1522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was backflow in an unspecified number of interlink solution administration sets while in use on a patient.It was stated that the nurse primed the iv (intravenous) tubing and filter and attached it to the patient¿s central line.The extension set was positioned near the patient¿s arm at or below the level of the patient¿s heart.Subsequently blood backed up into the filter.When the nurse picked up the set, the blood and fluid drained back to the patient, but after that there was no fluid (just air) in the line from the filter to the patient; further described as ¿drained dry¿ from the filter to the patient.The nurse exchanged the extension set several times (exact number unknown) and each time the same thing happened.Eventually the administration set did work after trying several new sets.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8429761
• Report Number: 1416980-2019-01459
• Device Sequence Number: 19492974
• Product Code: FPA
• UDI-Device Identifier: 00085412003993
• UDI-Public: (01)00085412003993
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: Health Professional
• Device Expiration Date: 10/04/2023
• Device Catalogue Number: 2C6671
• Device Lot Number: R18J04069
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/06/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1