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 11/15/2014

Event Type  malfunction  

Event Description

It was reported that a large volume infusor" reversed flow".This malfunction occurred before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received by baxter, but the evaluation has not yet been completed.A follow-up report will be submitted upon completion of the evaluation or if any additional relevant information is received.

Manufacturer Narrative

(b)(4).The device was manufactured august 26, 2014 to august 27, 2014.Evaluation summary: the sample was received for evaluation.Visual inspection revealed that there was a leak/backflow from the fill port.Further visual inspection revealed a particle trapped under the checkband.Fourier transform infrared spectroscopy revealed that the particle was made of polyethylene.The cause of the backflow was determined to be the particle.A capa 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; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4347008
• MDR Text Key: 5141637
• Report Number: 1416980-2014-46639
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 14H046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Date Manufacturer Received: 12/29/2014
• 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