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

Catalog Number 2C1071KJP

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that an infusor was leaking.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).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).The lot 14f005 was manufactured june 5, 2014 - june 6, 2014.The device was received for evaluation.Visual inspection on the device (via the naked eye) noted fluid inside the package that contained the device.When the device was removed from the packaging, the cause of fluid inside the package was visually identified to be an untightened blue winged luer cap.A functional testing was performed by filling the device with green colored water.After filling the device with the green water solution, the blue winged luer cap was hand tightened by manually rotating the cap until the cap could no longer be rotated.The device was monitored until the next day; as a result there were no signs of leak observed.The reported condition was not verified.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: 4376182
• MDR Text Key: 5260014
• Report Number: 1416980-2014-48189
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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: 06/01/2019
• Device Catalogue Number: 2C1071KJP
• Device Lot Number: 14F005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2015
• 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