MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; FILTER, INFUSION LINE

Catalog Number 2N3347

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a micro volume extension set would not flow.This occurred during simulated use testing of the device by the customer.It was stated that the device was tested with an unknown syringe, an unknown microbore extension set, and a non-baxter infusion pump.The reporter stated that the nurse ¿filled a syringe with saline first, connected the syringe to the pump directly, and tried to get flow to happen, but nothing would flow through the filter in the set.¿ the reporter further stated that the nurse ¿could bolus an amount of fluid through the filter, but no steady flow could be reached.¿ there was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.A trend alert review will be performed.A batch review will also be performed if the lot number of the device is received.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the actual device was not returned; however, 5 unused devices of the same lot were received for evaluation.Visual inspection did not identify any defects.Clear passage and pressure testing were performed with satisfactory results.The reported problem could not be confirmed for the actual device nor for any of the unused devices.A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3565199
• MDR Text Key: 4072688
• Report Number: 1416980-2014-01049
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2015
• Device Catalogue Number: 2N3347
• Device Lot Number: UR10G23112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2010
• 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