MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE INTERMATE; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C2112K

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received and evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the fill port junction of the large volume intermate cracked during filling with vancomycin.There was no patient involvement.No additional information provide.

Manufacturer Narrative

The device was received for evaluation containing approximately 120 ml of drug fluid in the bladder.During visual inspection, the fillport¿s lip was observed ¿chipped off on one side¿.The reported condition was verified; however, 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.

• Brand Name: INTERMATE
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• 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: 7732953
• MDR Text Key: 115550326
• Report Number: 1416980-2018-04737
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412487960
• UDI-Public: (01)00085412487960
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: 2C2112K
• Device Lot Number: 17G028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1