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 06/23/2014

Event Type  malfunction  

Event Description

It was reported that there was particulate matter inside the balloon of an infusor.There was no patient involvement.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).A capa has been opened to address this issue.If additional relevant information is obtained, then a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).Manufacture date was february 14, 2014 ¿ february 17, 2014.Evaluation: the device was received for evaluation.During visual inspection white particles ranging in size from 0.20 ¿ 0.30 mm were observed floating in the fluid within the bladder.Fourier transform infrared spectroscopy determined the particles to be polyester.The reported problem was verified.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 of the problem is unknown.Should additional relevant information become available, a follow-up mdr 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: 3944696
• MDR Text Key: 4644888
• Report Number: 1416980-2014-23289
• 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: 06/23/2014

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
• Is the Reporter a Health Professional?: No
• 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; 09/24/2014
• 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