MAUDE Adverse Event Report: BAXTER HEALTHCARE - GUANGZHOU; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 6AC4466H

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the sponge inside the minicap was dry.There was no patient injury or medical intervention indicated as a result of this event.No additional information is available.

Manufacturer Narrative

(b)(4).The sample was not available for evaluation.A review of all batch record documents was conducted 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 follow-up report will be submitted.

• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - GUANGZHOU; guangzhou econ &; tech dev dist; dong ji industrial 51073 0; CH 510730
• Manufacturer (Section G): BAXTER HEALTHCARE - GUANGZHOU; guangzhou econ &; tech dev dist; dong ji industrial 5107 30; CH 510730
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4032364
• MDR Text Key: 4805564
• Report Number: 1416980-2014-27832
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 6AC4466H
• Device Lot Number: GM1404006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/25/2014
• Date Device Manufactured: 04/08/2014
• 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