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

Catalog Number 2C1009K

Device Problem No Flow (2991)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported that a large volume infusor did not flow.The issue occurred during filling.There was no patient involvement.

Manufacturer Narrative

E1: initial reporter address: (b)(6).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.

Manufacturer Narrative

H4: the lot was manufactured on july 7, 2022, to july 8, 2022.H10: the device was received for evaluation.A visual inspection was performed which noted that the bladder from the sample had been ruptured to drain the drug fluid before returning the sample.Therefore, a functional flow test could not be performed.An examination of the tubing line and flow restrictor was performed which showed no evidence of a blockage.A blockage such as drug precipitate or air bubbles would typically be root causes of no flow after fill; however, no evidence of a blockage was found from the tubing line and flow restrictor in the sample.The reported condition was not verified.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: 17266590
• MDR Text Key: 318776926
• Report Number: 1416980-2023-03375
• Device Sequence Number: 1
• Product Code: MEB
• 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: 08/08/2023

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: 2C1009K
• Device Lot Number: 22G007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/08/2023
• 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