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

Catalog Number 2C2113K

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546); Material Twisted/Bent (2981)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that the balloon (bladder) of a large volume intermate was bent and pierced; there was a loss of 5 ml of product.This was identified during patient use, at the end of infusion.The device contained 180ml of alfalastin 6g.There was no report of patient injury or medical intervention associated with event.No additional information is available.

Manufacturer Narrative

Initial reporter address: (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

H10: the device was received for evaluation.Visual inspection was performed using the naked eye and noted that the bladder has been ruptured.Fluid from the ruptured bladder was expected to leak inside the housing of the device at the time the bladder ruptured.The ruptured bladder was examined for signs of abnormality and there were no signs of abnormality found on the bladder that may have led to the rupture.The reported condition was verified.The cause of the leak was due to the ruptured bladder, however the cause of the rupture 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.

• 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; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16725065
• MDR Text Key: 313141049
• Report Number: 1416980-2023-01711
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412487977
• UDI-Public: (01)00085412487977
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2C2113K
• Device Lot Number: 21H010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• 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
• Treatment: ALFALASTIN
• Patient Age: 76 YR
• Patient Sex: Female