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

Catalog Number 2C1009KC

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

It was reported that a large volume infusor leaked from the filling port.This occurred during filling with an unknown drug.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Manufacture date: september 3, 2012 ¿ september 4, 2012.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.As the sample was not returned, a device analysis cannot be completed.Should additional relevant information become available, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.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: 3887792
• MDR Text Key: 4540787
• Report Number: 1416980-2014-19843
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date: 05/28/2014

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: 09/01/2015
• Device Catalogue Number: 2C1009KC
• Device Lot Number: 12J001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 06/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2014
• 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