MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C1071KJP

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

It was reported that an intermate had particulate matter inside its balloon.There was no patient involvement.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).If additional relevant information is obtained, then a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).The lot was manufactured between february 14, 2014 and february 17, 2014.Evaluation summary: the device was returned for evaluation.Visual inspection noted solid, white particles, between 0.20 and 0.45 mm in size, floating in the fluid of the reservoir.Fourier transform infrared spectroscopy (ft-ir) scanning identified the particles to be polyester material.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.The cause or origin of the particles was unable to be determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).A capa has been initiated to investigate this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3944594
• MDR Text Key: 4603998
• Report Number: 1416980-2014-23276
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K062457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2014

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 Expiration Date: 02/01/2019
• Device Catalogue Number: 2C1071KJP
• Device Lot Number: 14B031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Initial Date Manufacturer Received: 08/31/2014
• Initial Date FDA Received: 07/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/18/2014; 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• 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