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 07/14/2014

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was particulate matter in the balloon of a single day infusor.This was noted during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Manufactured february 14, 2014 to february 17, 2014.A visual inspection identified a solid white particle, approximately 0.10 mm in size, floating in the fluid of the reservoir.During a fourier transform infrared spectroscopy scan it was determined that the particle was polyester.The cause of the particulate matter in the fluid path was not determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.If additional relevant information is obtained, then a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of the investigation, or if any additional relevant information is received, 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: 3988934
• MDR Text Key: 17076792
• Report Number: 1416980-2014-25705
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2014

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: Health Professional
• 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: 07/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 08/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/02/2014; 10/03/2014
• 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