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

Catalog Number 2C2063K

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume infusor tubing was damaged.Further described as the tubing appeared "chewed off".The event occurred while priming the tubing with normal saline (ns).This issue was discovered during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the device was manufactured from january 3, 2022 - january 5, 2022.H10: the actual device was received for evaluation.A visual inspection was performed using the naked eye which noted a segment on the tube set was damaged; further described as indentation marks from the flow wrap sealer equipment were observed on the damaged area of the tube set.The reported condition was verified.The cause of the condition was related to the manufacturing process.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: 16023463
• MDR Text Key: 308210412
• Report Number: 1416980-2022-06992
• Device Sequence Number: 1
• Product Code: MEB
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• 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