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

Catalog Number 2C1009KP

Device Problem Fluid/Blood Leak (1250)

Patient Problem Thromboembolism (2654)

Event Type  malfunction  

Manufacturer Narrative

Report late due to transition from vmsr program.This report was initially reported to the fda through vmsr report # 1416980-2020-00293.(b)(6).Lot 19c034 was manufactured from march 22-25, 2019.The device was received for evaluation.Visual inspection revealed fluid inside the bag that contained the device.When the device was removed from the bag, the cause of the fluid was found to be an untightened blue winged luer cap.A functional leak test was performed by filling the device with water and manually tightening the blue winged luer cap.During and after fill, no signs of a leak were observed from the sample.The reported condition was not verified.The device was found to be conforming product.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 leaked from an unspecified location prior to patient use.There was no patient involvement.No additional information is available.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10336608
• MDR Text Key: 200763305
• Report Number: 1416980-2020-04455
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081373
• UDI-Public: (01)00085412081373
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/28/2020

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: 2C1009KP
• Device Lot Number: 19C034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 07/29/2020
• 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