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

Catalog Number J2C1711

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2021

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 bladder of a small volume infusor ruptured.The bladder ruptured occurred while filling the device with medication prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: the lot was manufactured between august 28, 2020 - august 31, 2020.H10: the device was received for evaluation.Visual inspection on the returned unit via the naked eye noted the bladder has been ruptured.The ruptured bladder was examined for signs of abnormality that could have caused the rupture and no issues were noted.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause of the condition is manufacturing related.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: 11334041
• MDR Text Key: 245938170
• Report Number: 1416980-2021-00677
• Device Sequence Number: 1
• Product Code: MEB
• 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: 03/05/2021

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: Other
• Device Catalogue Number: J2C1711
• Device Lot Number: 20H045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/21/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1