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

Catalog Number 2C2122K

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The event occurred on an unspecified date of (b)(6) 2018.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 a large volume intermate had an unspecified cap separated in the overpouch.The was observed prior to use.There was no patient involvement. no additional information is available.

Manufacturer Narrative

The lot number was manufactured between august 28, 2017 ¿ august 29, 2017.The device evaluation was completed.Visual inspection on the returned unit with the naked eye revealed that the fill port cap was detached.The reported condition was verified.The cause of the reported condition was due a manufacturing assembly error.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 - 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: 8180053
• MDR Text Key: 130894745
• Report Number: 1416980-2018-07892
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2122K
• Device Lot Number: 17H013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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