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

Catalog Number 2C2063K

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

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 the tubing of a large volume infusor broke off.This issue occurred when staff was straightening the tubing during set up.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from january 03, 2022 - january 05, 2022.H10: the device was received for evaluation.Visual inspection was performed using the naked eye and the tubing was observed cut off in two pieces.The cut was observed to be jagged, not smooth.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to how the product was being handled upon removing from the package.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: 16195732
• MDR Text Key: 307633048
• Report Number: 1416980-2023-00069
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579412
• UDI-Public: (01)00085412579412
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 02/17/2023

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: 2C2063K
• Device Lot Number: 22A001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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