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

Catalog Number 2C8571

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

Hold am it was reported that there was backflow through a clearlink continu-flo solution administration set.It was further reported that the back flow was observed from the piggyback solution which contained lipids towards the primary container of total parenteral nutrition.The medication was pumped using a baxter sigma pump.The solution set was connected to a clearlink duo-vent continu-flo solution set.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure testing and clear passage testing was performed with no issue noted.Functional flow rate testing was also performed with no issues noted.Backflow functional testing was performed with no issues noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO 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: 8184830
• MDR Text Key: 131056638
• Report Number: 1416980-2018-07933
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412046327
• UDI-Public: (01)00085412046327
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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: 08/28/2023
• Device Catalogue Number: 2C8571
• Device Lot Number: R18H28129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/19/2019
• Supplement Dates FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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
• Treatment: BAXTER SIGMA PUMP; CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET