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

Catalog Number 2C1009K

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two (2) large volume infusors were leaking from the luer connector.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured from october 26, 2018 - october 30, 2018.Two (2) actual devices were received for evaluation.Visual inspection was performed and one of the two samples did not contain fluid in the bladder because the tubing line had been cut and the fluid drained out of the bladder.The blue winged luer cap was observed to be slightly untightened.The tubing line was reconnected and a functional leak test was performed by filling the bladder of the two samples.After fill, the samples were primed and then the blue winged luer cap was placed back onto the distal luer and securely hand tightened.The samples were monitored until the next day and no signs of leak were observed.The reported condition was not verified.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: 9532437
• MDR Text Key: 173196433
• Report Number: 1416980-2019-07255
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412022529
• UDI-Public: (01)00085412022529
• 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

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 2C1009K
• Device Lot Number: 18K020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1