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

Catalog Number 2C1009K

Device Problem Break (1069)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: e1: initial reporter address: (b)(6) e1: initial reporter city: e1: initial reporter postal code: (b)(6) the device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified syringe broke inside the fill port of a large volume infusor.The occurred during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: the lot was manufactured from may 12, 2022, to may 14, 2022.H10: the actual device was received for evaluation.A visual inspection noted a broken syringe tip stuck inside the fill port.The broken syringe tip was a non-baxter product.The syringe tip was removed from the fill port and a similar syringe was used to test the unit.During the functional test, the syringe was gently turned in a counterclockwise direction to remove the syringe from the fill port, and as a result, the syringe tip did not break.Measurement of the infusor's fill port was found to be within specification.The reported condition was not verified.The unit 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: 17913252
• MDR Text Key: 325403665
• Report Number: 1416980-2023-05161
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412022529
• UDI-Public: (01)00085412022529
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 11/14/2023

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: Health Professional
• Device Catalogue Number: 2C1009K
• Device Lot Number: 22E012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/14/2023
• 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