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

Catalog Number 2C6671

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8429761
• MDR Text Key: 139450784
• Report Number: 1416980-2019-01459
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412003993
• UDI-Public: (01)00085412003993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2023
• Device Catalogue Number: 2C6671
• Device Lot Number: R18J04069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/06/2019
• Supplement Dates FDA Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1