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

Catalog Number J2C1155

Device Problems Material Rupture (1546); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

It was reported that the bladder of a large volume multirate infusor ruptured.This occurred during manual filling with a syringe of an unknown drug.It is unknown if the ruptured bladder detached from the assembly but it was not in the footed position.It is unknown whether the device was in direct sunlight.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device is reported to be available for evaluation, and a request for its return has been made.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 3759433
• MDR Text Key: 4420480
• Report Number: 1416980-2014-12613
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2014

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 Catalogue Number: J2C1155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 04/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2014
• 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