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

Catalog Number J2C1702

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the bladder of a small volume infusor ruptured during filling.The device was filled with unspecified medication manually with a syringe.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4, and h6.H4: the lot was manufactured from february 05, 2020 - february 06, 2020.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that the bladder had been ruptured.The ruptured bladder was examined for signs of abnormality that may have potentially caused the rupture problem and no signs of abnormality were found.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was a manufacturing 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
• MDR Report Key: 11348756
• MDR Text Key: 232559438
• Report Number: 1416980-2021-00738
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412083285
• UDI-Public: (01)00085412083285
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

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: J2C1702
• Device Lot Number: 20B013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1