MAUDE Adverse Event Report: BAXTER HEALTHCARE ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2H8519

Device Problems Leak/Splash (1354); Chemical Spillage (2894); Connection Problem (2900)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

It was reported that while using a clearlink continu-flo primary iv (intravenous) tubing set, a healthcare provider (hp) experienced a connection issue which caused chemotherapy drug to leak onto the hp causing a severe allergic reaction.It was reported that during set up of a chemotherapy infusion by the hp, the baxter secondary set fell out of the port of a non-baxter solution bag which was hanging on an iv pole causing, paxiltaxel, chemotherapy agent to spill onto the hp causing a severe allergic reaction.The hp required an unspecified medical intervention.At the time of this report, the hp was recovered from the event.Additional information was requested but is not available.This is report 2 of 2 involved in this event.

Manufacturer Narrative

Complaint no: (b)(4).The device was not returned and the lot number is unknown, therefore, a device analysis cannot be completed.The cause is unknown.Should additional relevant information become available, a follow-up will be submitted.Same patient as (b)(4).

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3875613
• MDR Text Key: 4511062
• Report Number: 1416980-2014-19197
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H8519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HOSPIRA (B)(4) 0.9% SODIUM CHLORIDE IV SOLN,250 ML; HOSPIRA (B)(4) 0.9% SODIUM CHLORIDE SOLN 1000 ML; CLEARLINK MED SET, NON DEHP ¿ SECONDARY SET; HOSPIRA (B)(4) 0.9% SODIUM CHLORIDE IV SOLN 500 ML
• Patient Outcome(s): Required Intervention