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

Catalog Number 2C7462

Device Problems Tear, Rip or Hole in Device Packaging (2385); Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the clamp of a clearlink secondary medication set ripped the tubing, leading to a chemotherapy spill.This occurred during patient infusion.The device was being used in a setup with a paclitaxel set and a sigma infusion pump at the time of the event.The reporter stated that the patient had begun the infusion of chemotherapy at a rate of 20ml/hr; the infusion rate was raised to 200ml/hr when the device was hooked up to the sigma pump.The customer reported that this was when the leak appeared to be coming from ¿right below the filter.¿ there was no report of patient injury or medical intervention associated with this event.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3809233
• MDR Text Key: 4367344
• Report Number: 1416980-2014-15458
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C7462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• 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: CHEMOTHERAPY; PACLITAXEL SET (2C8858); SIGMA SPECTRUM PUMP