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

Catalog Number 6AC4466

Device Problem Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the minicap sponge came out from the minicap.This was found before use.There was no patient involvement.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).The device was returned to baxter and an evaluation was performed.A review of all batch record documents was performed for lot number gm1402101 with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported problem were noted.A visual inspection was performed and the minicap was found opened and the sponge was inside of foil pouch but out of the mini cap.The reported problem was verified via visual inspection.The cause for the reported problem was undetermined.In order to further investigate this condition, a capa was opened.Should additional relevant information become available, a follow-up report will be submitted.

• Brand Name: MINICAP
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - GUANGZHOU; jiao yuan road, dong ji indust; guangzhou 51073 0; CH 510730
• Manufacturer (Section G): BAXTER HEALTHCARE - GUANGZHOU; jiao yuan road, dong ji indust; guangzhou 5107 30; CH 510730
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4102230
• MDR Text Key: 4717371
• Report Number: 1416980-2014-32269
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2014

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: Other
• Device Catalogue Number: 6AC4466
• Device Lot Number: GM1402101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2014
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• 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