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

Catalog Number 2C9960KP

Device Problems Backflow (1064); Fluid/Blood Leak (1250); 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 was reported that a large volume multirate infusor had return (backflow) and the unspecified medication did not infuse.The issue was identified during patient use.There was blood inside the tubing and blood around the connection of the tubing and the multi-rate flow control module.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: the lot was manufactured from june 30, 2022 to july 1, 2022.H10: the actual device was received for evaluation.A visual inspection noted a leak coming out at the junction of the tubing and the module post.Examination of the leak area revealed the cause of the leak was due to a surface cut located on the tubing.The reported condition of leak was verified.The cause of the condition could not be determined.A functional flow rate test was also performed on the unit and the results were found to be within the product specification range.Evidence of continuous flow of fluid was observed during the flow test.The reported condition of ¿did not infuse¿ was not verified during the sample evaluation.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: 17481239
• MDR Text Key: 320914414
• Report Number: 1416980-2023-03972
• 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: 08/08/2023
• 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