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

Catalog Number 2C1082KJP

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: the lot was manufactured from february 25, 2014-february 26, 2014.The device was received for evaluation.Visual inspection noted fluid inside the housing, indicating leakage had occurred.The leak was determined to be due to a broken volume indicator post.The reported condition was verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the broken volume indicator post was not determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the volume indicator post of a seven day infusor fractured, leading to a leak in the housing of the device.This was noted approximately 9 hours and 20 minutes after the start of a simulated infusion.The device had been filled with 5% dextrose solution.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received and is currently awaiting evaluation.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: 4532457
• MDR Text Key: 13078126
• Report Number: 1416980-2015-06552
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2014

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: Other
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 2C1082KJP
• Device Lot Number: 14B054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/26/2015; 04/29/2015
• 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