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

Catalog Number J2C1009

Device Problem Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

It was reported that there were "cuts or scratches" on the bladder of a large volume infusor.This was noted after filling and before patient use.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.Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was manufactured 08 july 2013 to 10 july 2013.Evaluation summary: the actual device was received for evaluation with 250ml of fluid in its bladder.Visual inspection of the device found two lines resembling scratch marks, 4.3 mm and 5.3 mm in length, on the outer surface of the inflated reservoir.The cause of the condition could not be determined.A capa has been opened to further investigate the 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3903253
• MDR Text Key: 4676721
• Report Number: 1416980-2014-20946
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: J2C1009
• Device Lot Number: 13G033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2014
• 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