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

Catalog Number ASKU

Device Problems Filling Problem (1233); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

It was reported that the infusion of four (4) elastomeric devices slowed down and ran longer than expected.The expected therapy time was between 30-40 minutes; however, the devices ran between 40-45 minutes.This was discovered during patient infusion.The clamp on the bottles was causing a kink.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B3/d10: the events occurred between (b)(6)2023 and (b)(6)2023.E1: initial reporter postal code: 8146.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The devices were not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• 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: 17173192
• MDR Text Key: 317629593
• Report Number: 1416980-2023-03079
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 07/27/2023

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: Other
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 07/27/2023
• 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