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

Catalog Number 2C1073KJP

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was manufactured july 10, 2014-july 11, 2014.The device was recieved for evaluation.Visual inspection revealed a solid white fragment of the duckbill valve component approximately 1.30mm in size, floating in the fluid of the reservoir.The particle was identified to be polyisoprene material via ft-ir spectrophotometer scanning, which is the material of the duckbill valve.The reported problem was verified.The cause of the problem could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During product evaluation, it was identified that there were solid white particles floating in the bladder of a half day infusor.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.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: 4376322
• MDR Text Key: 12907520
• Report Number: 1416980-2014-48213
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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: 07/01/2019
• Device Catalogue Number: 2C1073KJP
• Device Lot Number: 14G020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2015
• 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