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

Catalog Number J2C1071J

Device Problems Material Rupture (1546); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

It was reported that the bladder of a single day infusor ruptured.This occurred during filling, with a syringe, of an unknown drug.The ruptured bladder was not in the footed position.Prior to the event, the bladder was not exposed to direct sunlight and the coiled tubing was not tangled or stuck in between the housing and the volume indicator.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned and is currently in the process of being evaluated.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The lot was manufactured april 14, 2011 ¿ april 15, 2011.The sample was received for evaluation.A visual inspection noted fluid inside the housing; however, no evidence of rupture was found on the reservoir.The reservoir was found to be fully intact.A functional test was subsequently performed by filling the reservoir with green colored water.After fill, no evidence of rupture was observed on the reservoir; the reported problem was not verified.However, a leak was noted at the welded area of the volume indicator port located inside the housing.(b)(4).A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.If additional relevant information is obtained, then a follow-up mdr 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: 3846724
• MDR Text Key: 4658218
• Report Number: 1416980-2014-17843
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2014

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: 12/31/2015
• Device Catalogue Number: J2C1071J
• Device Lot Number: 11D024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 06/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/18/2014
• 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