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

Catalog Number 2C8671

Device Problems Reflux within Device (1522); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: central line tunneled hickman central line, epoprostenol (veletri), sigma infusion pump, unknown primary iv access set with filter.(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was blood backflow through a clearlink extension set.The patient had a central line tunneled hickman central line access and was being treated with epoprostenol at 2.6 ml/hr.The customer stated the nurses attached the primary line to an iv solution bag containing epoprostenol and attached a filter to the clearlink clave.Prior to starting the infusion of epoprostenol, the nurses primed the extension set and unknown primary iv access set with filter.After the lines were prepped, the nurse loaded the iv into a baxter pump and connected it to the patient¿s central line access.Within a few minutes, the patient noticed blood backing up the iv lines ¿prior to the filter¿ and informed the nurses.The reporter stated that there was also air in the line as the pump presented an upstream occlusion alarm.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: CLEARLINK 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: 7339142
• MDR Text Key: 102407156
• Report Number: 1416980-2018-01351
• Device Sequence Number: 1
• Product Code: FPA
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8671
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CENTRAL LINE; EPOPROSTENOL; PUMP; UNKNOWN PRIMARY IV
• Patient Age: 71 YR