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

Catalog Number 2C1009KP

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two (2) large volume infusors leaked having the blue winged cap at the end of the tubing.The leaks occurred when the tubing was being filled without the need to open the blue cap.The reported thought the blue caps were not "leak proof." the devices contained normal saline.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was manufactured from march 22, 2019 - march 25, 2019.Two (2) devices were received for evaluation.During visual inspection via the naked eye, fluid was observed inside the bag that contained the unit.When the unit was removed from the bag, the cause of fluid inside the bag was visually identified to be untightened blue winged luer cap.Functional testing was performed, the blue winged luer cap was hand tightened by manually rotating the cap until the cap could no longer be rotated.The unit was monitored for twenty-four hours.No signs of leak were observed at the blue winged luer cap of either device.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.A nonconformance has been opened to address this issue.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
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9532914
• MDR Text Key: 173201690
• Report Number: 1416980-2019-07272
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081373
• UDI-Public: (01)00085412081373
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071222
• 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,Followup
• Report Date: 02/06/2020

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: 01/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1