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

Catalog Number 2C1009KP

Device Problem Reflux within Device (1522)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing date -- july 14, 2016 ¿ july 15, 2016.The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection was performed with no issues noted.A functional test was performed by manually filling the bladder with green color water, there were no evidence of leaks before or after filling.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume infusor was "behaving abnormally" during filling.At first, the device went to significant back pressure and then it flowed abnormally.There was no patient involvement.No additional information is available.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6519012
• MDR Text Key: 73607795
• Report Number: 1416980-2017-03611
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/25/2017

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 Catalogue Number: 2C1009KP
• Device Lot Number: 16G018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1