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

Catalog Number 2C9960KP

Device Problem No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It as reported that the two (2) large volume multirate infusors did not infuse the medicine.The device did not purge, nor did it perform forced purging with three-way valves and a syringe.The issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction b5: change quantity to one (1), previously reported as two (2) devices.H4: the device was manufactured from june 30, 2022 ¿ july 1, 2022.H10: the device was received for evaluation.A visual inspection with the naked eye was performed which did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and the results 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: 17458247
• MDR Text Key: 320390271
• Report Number: 1416980-2023-03919
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081496
• UDI-Public: (01)00085412081496
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K011317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C9960KP
• Device Lot Number: 22F038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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