MAUDE Adverse Event Report: BAXTER HEALTHCARE ACCESS; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2C0415

Device Problem Material Opacification (1426)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection (via the naked eye) did not reveal any discoloration or other nonconformities.An underwater pressure and functional flow test was performed, however, no malfunction was observed.The reported condition of discoloration could not be verified.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after a hospira sterile water bag was spiked using a solution transfer set, the sterile water appeared cloudy after going through the set.This occurred during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for analysis and an evaluation has begun but has not yet been completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• 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: 4245774
• MDR Text Key: 12816141
• Report Number: 1416980-2014-40132
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C0415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2014
• 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: Unknown
• Patient Sequence Number: 1