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

Catalog Number J2C1711

Device Problem No Flow (2991)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

A1: should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume infusor stopped infusing.After ¿two days¿ the device was observed with ¿most of drug solution" remaining.The total fill volume was 100ml of an unspecified drug solution.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4, h6, and h10: the lot was manufactured between june 6, 2023 ¿ june 8, 2023.The device was received for evaluation with 101ml of fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported flow problem.A functional flow rate test was performed on the sample, and the flow rates were found to be within the product specification range.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
• 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: 19208989
• MDR Text Key: 341535971
• Report Number: 1416980-2024-01955
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04987456508334
• UDI-Public: (01)04987456508334
• 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: 05/21/2024

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: 23F003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/21/2024
• 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