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

Catalog Number 2C1009K

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This lot was manufactured from february 27, 2014- march 1, 2014.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the "constant speed regulator" of a large volume infusor was damaged and leaking.This occurred before patient use.There was no patient involvement.No additional information is available.

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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4376349
• MDR Text Key: 12889244
• Report Number: 1416980-2014-48221
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• 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: 12/07/2014

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: 02/01/2017
• Device Catalogue Number: 2C1009K
• Device Lot Number: 14B043
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2015
• 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