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

Catalog Number 2C1009K

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2016

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 rupture occurred during filling of a large volume infusor.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot 15g019 was manufactured july 15, 2015- july 16, 2015.The actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the photograph the ruptured bladder was observed.The reported condition was verified; however the cause of the condition could not be determined.A nonconformance 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; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong ave.; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6182710
• MDR Text Key: 62683507
• Report Number: 1416980-2016-18479
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1009K
• Device Lot Number: 15G019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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