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

Catalog Number 2C2008K

Device Problems Backflow (1064); Crack (1135)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter last name:.E1: initial reporter facility name:.E1: initial reporter address: (b)(6).E1: initial reporter city:.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume infusor had back flow due to a crack.This was observed during preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: h3, h4, h6, h10.H4: the lot was manufactured july 12-15, 2023.H10: the actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photographs observed droplets of fluid located inside a yellow bag that contained the device suggesting a leak may have occurred.The reported condition was verified.The cause of the condition could not be determined.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: 18615662
• MDR Text Key: 334290484
• Report Number: 1416980-2024-00264
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579382
• UDI-Public: (01)00085412579382
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2008K
• Device Lot Number: 23G022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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: NA.