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

Catalog Number 2C2120K

Device Problem Material Rupture (1546)

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

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter city: (b)(6).H4: the lot was manufactured from november 04, 2022 - november 05, 2022.H10: the device was received for evaluation.A visual inspection was performed and the bladder was observed ruptured.The ruptured bladder was further examined to identify any issues that could have caused the rupture.No signs of abnormality were observed.The reported condition was verified.The cause of the condition could not be determined.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.

Event Description

During evaluation, the bladder of a large volume intermate was found ruptured.There was no patient involvement.No additional information is available.

• Brand Name: INTERMATE
• Type of Device: PUMP, INFUSION
• 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: 17837604
• MDR Text Key: 324580002
• Report Number: 1416980-2023-04920
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412487922
• UDI-Public: (01)00085412487922
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• 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
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2120K
• Device Lot Number: 22M002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• 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