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

Catalog Number J2C1702

Device Problems Fluid/Blood Leak (1250); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2023

Event Type  malfunction  

Event Description

It was reported that a small volume infusor had delivery stopped.After priming, delivery was started but the bladder did not deflate enough.It was further reported that there was a leak from the connection part between the infusor luer lock and a non baxter needle.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

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.

Manufacturer Narrative

Additional information was added to h3, h4, h6, and h10.H4: the lot was manufactured from december 21, 2021 to december 22, 2021.H10: the device was received for evaluation with 35 ml of fluid in the bladder.A non-baxter connector line was attached to the device's luer.Visual inspection did not identify any abnormalities that could have contributed to the reported conditions.A functional flow rate test was performed and the flow rates were found to be within the product specification range.During the flow test, evidence of continuous flow was observed.No evidence of leak was observed during the flow test.The reported conditions were not verified.The sample was determined to be a 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.

• 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: 17556507
• MDR Text Key: 321275766
• Report Number: 1416980-2023-04106
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412083285
• UDI-Public: (01)00085412083285
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

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: J2C1702
• Device Lot Number: 21N033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/19/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: HUBER NEEDLE (NOT BAXTER PRODUCT)