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

Catalog Number 2C2113K

Device Problem Material Rupture (1546)

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

Event Date 06/14/2022

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 balloon of a large volume intermate burst.This issue was identified during patient infusion with alphalastin, approximately 45-60 minutes after treatment started.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufactured on july 28, 2021- july 30, 2021.H10: the device was received for evaluation.A visual inspection on the returned unit via the naked eye noted the bladder had been ruptured in a footing position which suggested the bladder ruptured at the end of patient infusion.The ruptured bladder was examined for signs of abnormality that could have caused the issue.There were no signs of abnormality found on the bladder that may have led to the rupture, and therefore root cause could not be determined.Possible root cause for the bladder rupture may be due to inherent variation in the material, as bladders are manufactured with rubber.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; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15676937
• MDR Text Key: 303154396
• Report Number: 1416980-2022-05734
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2113K
• Device Lot Number: 21G014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• 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
• Treatment: ALPHALASTIN
• Patient Age: 64 YR
• Patient Sex: Female