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

Catalog Number 2C1009KP

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

Device manufacture date: (b)(6) 2018.The actual sample was received at the plant for analysis.Visual inspection on the returned unit via the naked eye noted evidence of leak/backflow at the fill port when the fill port cap was removed.Further inspection on the unit revealed the cause of the leak/backflow was due to a white particle approximately 1.48mm in length lodged under the device check band.The particulate sample was analyzed using attenuated total reflectance fourier transform infrared spectroscopy (atr-ftir) and it was determined the particle was consistent with acrylic material.The reported issue was verified.The cause of the particle was not determined.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.

Event Description

It was reported that a large volume infusor presented a backflow from the injection site.This event occurred during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available at this time.

• 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 avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7575750
• MDR Text Key: 110366785
• Report Number: 1416980-2018-03451
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081373
• UDI-Public: (01)00085412081373
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K071222
• 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
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 18A023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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