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

Catalog Number 2C1073KJP

Device Problems Device Inoperable (1663); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot number 13n050 was manufactured december 19, 2013 ¿ december 20, 2013.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Spectroscopic evaluation of the device determined the particulate matter to be epoxy resin.The origin of this particulate remains undetermined.Should additional relevant information become available, a follow-up mdr will be submitted.

Event Description

It was reported that an infusor had a black particle on the inner coil tubing.This malfunction was observed during inspection; after compounding (filling) the device with an antibiotic drug.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).Initial reporter: address, fax number and international phone number: (b)(6).The infusor was received for evaluation.During visual inspection a tiny loose black particle, approximately 0.04 mm in size, was observed.The particle was located on the outer surface of the coiled tubing inside the housing; outside of the fluid path.A batch review will be performed.  if any relevant information is obtained that is related to the reported event, 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: 3748603
• MDR Text Key: 11818815
• Report Number: 1416980-2014-12113
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: 2C1073KJP
• Device Lot Number: 13N050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• 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