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

Catalog Number J2C1067

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 04/18/2014

Event Type  malfunction  

Event Description

It was reported that an overinfusion occurred during use of a patient control module.The device was being used in a setup with a large volume basal bolus infusor.The reporter stated that the expected infusion time was 48 hours, but the actual infusion ended in one day.There was no patient injury or medical intervention associated with this event.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: PUMP, INFUSION, PCA
• 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: 3815346
• MDR Text Key: 4504579
• Report Number: 1416980-2014-15818
• Device Sequence Number: 1
• Product Code: MEA
• 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
• Report Date: 04/22/2014

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 Catalogue Number: J2C1067
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/16/2014
• 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
• Treatment: LV BASAL BOLUS INFUSOR (J2C0216)