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

Catalog Number 2R8537

Device Problem No Flow (2991)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

A2: age at time of event; the patient is an adult.E1: initial reporter facility name: (b)(6).G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient was receiving an infusion of an unreported vasopressor with a clearlink solution set.It was further reported that the tubing at the bottom of the drip chamber was kinked and there was no medication flow, which was not noticed at the time of use.Priming occurred without any issues and no alarms were generated.The patient experienced severe hypotension and a ¿code purple¿ was issued."medication by injection and several boluses to keep the patient alive" was administered.The reporter stated that they had no further details as the patient was being treated in the intensive care unit.No additional information is available.

Manufacturer Narrative

Three (3) unused samples and a photograph were received for evaluation.Visual inspection with the naked eye was performed of the picture and the kinked tubing was observed.All three samples arrived unused in an over pouch.Each sample was numbered and visually inspected out of the over pouch.A kink in the tubing just below the drip chamber was observed.The reported condition was verified.All three samples were functionally tested by spiking into an in-house solution bag containing reverse osmosis water.Each sample was then primed and checked for flow.All three samples primed and flowed normally with no issues noted.Pressure test and clear passage under water were performed and no issues were noted.The cause of the condition could not be determined.A nonconformance has been opened to address this issue.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: CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18119210
• MDR Text Key: 327924773
• Report Number: 1416980-2023-05855
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412565743
• UDI-Public: (01)00085412565743
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K180739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2R8537
• Device Lot Number: R23G19086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SPECTRUM IQ PUMP
• Patient Outcome(s): Required Intervention