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

Catalog Number 2C9961KP

Device Problems Fluid/Blood Leak (1250); Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a large volume infusor leaked from a cut on the tubing.This was noted during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection noted a cut on the tubing.A functional leak test was performed and a leak was identified at the cut location of the tubing.The reported condition was verified.A capa has been opened to address this issue.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.

• 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: 5148243
• MDR Text Key: 28229118
• Report Number: 1416980-2015-38887
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K011317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2C9961KP
• Device Lot Number: 15C032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2015
• 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