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

Catalog Number 2C1009KP

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that nurse found the housing cap of a large volume infusor to be abnormal, before patient use.No additional information is available.

Manufacturer Narrative

(b)(4).The lot 13e022 was manufactured may 8, 2013 - may 9, 2013.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.One sample was received at the plant for evaluation.No defect was observed during visual inspection.The housing cap, clear fill-port cap, and blue winged luer cap were found to be in their normal condition.All caps fit properly to their parts.Initial evaluation didn¿t confirm the reported condition.Upon completion of baxter's investigation, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).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: 3698806
• MDR Text Key: 4235082
• Report Number: 1416980-2014-09831
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 13E022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2014
• 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