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

Catalog Number 2C1063KP

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

It was reported that the fill port of a large volume infusor fractured.According to the report, this occurred during filling using a syringe, as the syringe was being twisted.The solution being filled was not reported.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).(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

(b)(4).This lot was manufactured from may 24 2014 to may 27, 2014.Evaluation summary: the sample was returned for evaluation.A visual inspection identified that there was an unknown syringe tip was broken off and stuck inside the infusor's fill-port.There was no evidence indicating that the infusor's fill-port was fractured or defective.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: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4385733
• MDR Text Key: 5263407
• Report Number: 1416980-2015-00475
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 14E051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 01/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2015
• 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: Unknown
• Patient Sequence Number: 1