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

Catalog Number 2H8519

Device Problem Backflow (1064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was backflow of intravenous (iv) iron through an unspecified access primary set.It was stated that during the administration of iron iv via clearlink system secondary medication set through a colleague pump (rate of 125 ml/hr), the nurse noticed that the iron was moving up through the primary set.This issue was identified during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

This event occurred during an unknown date of (b)(6) 2021.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: the affected product was "clearlink system non-dehp continu-flo solution set", previously submitted as "unspecified access primary set".The affected quantity is two (2) [previously submitted as one (1)].D1: brand name: clearlink continu-flo solution set (previously submitted as ni) d4: catalogue #: "2h8519", previously submitted as "asku".G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial g4: 510k #: "k961225", previously submitted as "ni".H10: the devices were discarded 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.

• Brand Name: CLEARLINK CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12771471
• MDR Text Key: 280542648
• Report Number: 1416980-2021-06635
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K961225
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H8519
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• 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: CLEARLINK SYSTEM SECONDARY MEDICATION SET; COLLEAGUE PUMP; IRON IV