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

Catalog Number J2C1711

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a leak was observed between the luer adaptor and the blue winged luer cap of a large volume infusor.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction to d4: catalogue #.D4: correction was made to the previously submitted catalogue #; incorrectly reported.H4: the lot was manufactured from april 23, 2019 - april 24, 2019.H10: the actual device was received for evaluation.A visual inspection was performed using the naked eye noted fluid inside the bag that contained the unit.When the unit was removed from the bag, an untightened blue winged luer cap was found.Functional testing was performed by filling the device with green colored water.After fill, the blue winged luer cap was hand tightened.The device was being monitored until the next day and no signs of leak were observed.The device was found to be conforming product.The reported condition was not verified during functional testing.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 CORPORATION; deerfield IL
• MDR Report Key: 9512800
• MDR Text Key: 172606661
• Report Number: 1416980-2019-07129
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: J2C1711
• Device Lot Number: 19D061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 12/01/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1