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

Catalog Number 2C1009KP

Device Problems Fluid/Blood Leak (1250); Reflux within Device (1522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a large volume infusor leaked.The leak site was described as ¿by the filling point / filler neck¿as if there is a return run of the fluid¿, indicating backflow from the fill port occurred.This occurred during filling with an unspecified solution.There was no patient involvement.No additional information is available.This is report 2 of 2.

Manufacturer Narrative

(b)(4).The lot 14f055 was manufactured on june 27, 2014 to june 28, 2014.A review of all batch record documents was performed with no issues noted during the manufacturing process.One actual unit was received at the plant for evaluation.The unit was returned with approximately 100 ml of fluid in its bladder.A visual inspection on the unit (via the naked eye) revealed evidence of leak (backflow) at the fill-port when the fill-port cap was removed.Further visual inspection on the unit revealed the direct cause of the leak (backflow) problem was due to a particle approximately 0.60 mm in size, trapped under the check-band.The particle was identified to be acrylic material via fourier transform infrared spectroscopy (ftir)scanning.A capa was opened for further investigation.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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4225509
• MDR Text Key: 4996402
• Report Number: 1416980-2014-38818
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K071222
• 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
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 14F055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Date Manufacturer Received: 10/10/2014
• 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