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

Catalog Number J2C1711

Device Problem Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2014

Event Type  malfunction  

Event Description

A nurse reported that the solution in their infusor elastomeric device did not deliver according to their desires.According to the report, the nurse noted the amount of solution appeared not to decrease after the patient connected to the device for infusion.The solution in use is unknown.There was patient involvement; however, no patient injury, medical intervention, or adverse reaction is associated with the reported condition.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is underway.Upon completion of baxter's investigation, if additional relevant information is obtained, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was manufactured september 6, 2013 to september 9, 2013.Evaluation summary: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional test was performed by removing the luer cap from the unit¿s distal luer.Evidence of flow was visually observed at the distal luer and continued to flow without stopping.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: 3898405
• MDR Text Key: 16805049
• Report Number: 1416980-2014-20405
• 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,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: J2C1711
• Device Lot Number: 13J011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• 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