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

Catalog Number 2C1009K

Device Problem Material Rupture (1546)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume infusor had ruptured during patient infusion.Approximately 40ml of unspecified liquid remained in the device.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufactured on february 16, 2022-february 17, 2022.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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: 17139917
• MDR Text Key: 317584436
• Report Number: 1416980-2023-02940
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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: 22B022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/18/2023
• 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