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

Catalog Number J2C1009

Device Problems Material Rupture (1546); Material Deformation (2976)

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

Event Date 09/04/2022

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the bladder of a large volume infusor ruptured during patient infusion.The bladder was observed to be deformed before the rupture.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from february 01, 2022 - february 02, 2022.H10: the actual device was received for evaluation.A visual inspection performed using the naked eye found the bladder had been ruptured.The bladder ruptured in a footing position which suggested the rupture may have occurred towards the very end of infusion.The ruptured bladder was examined for signs of abnormality that may have potentially caused the rupture problem.No signs of abnormality were found.There was no evidence of deformation found from the ruptured bladder.The reported condition was verified.The cause of the condition was not determined; however the most probable cause is a manufacturing related issue.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 ; 2242702068
• MDR Report Key: 15510967
• MDR Text Key: 301503721
• Report Number: 1416980-2022-05193
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412083193
• UDI-Public: (01)00085412083193
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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: Lay User/Patient
• Device Catalogue Number: J2C1009
• Device Lot Number: 22B001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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