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

Catalog Number J2C1009

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

The device was manufactured between 10 feb 2017 and 11 feb 2017.The device was received for evaluation with a connector (non-baxter product) attached to the infusor¿s fill port.A syringe (non-baxter product) was also returned to the plant with a connector (non-baxter product) attached to the tip of the syringe.During visual inspection via the naked eye, two vertical cracks were noted.Functional testing was performed and a leak was observed at the cracks.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified; however, the cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a large volume infusor leaked.After fill with an unspecified volume of saline, a leak was observed from the fill port due to a crack at the fill port.There was no patient involvement.No additional information is available.

• Brand Name: INFUSOR
• 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: 7186602
• MDR Text Key: 97403121
• Report Number: 1416980-2018-00094
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: J2C1009
• Device Lot Number: 17B024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• 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