MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC X SYSTEMS CENTRIFUGE; CENTRIFUGE (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Catalog Number 09527-26

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and a review of device history.The customer observed smoke coming from the digtl centr (ref)/xsystems centrifuge (list number 09527-26) while tacrolimus pretreatment tubes were being centrifuged.The field service engineer (fse) replaced the xsystems centrifuge to resolve the issue.The fse verified that the electrical specification of the power source met the outline specifications of the xsystems centrifuge instruction guide.A search of complaints determined that there is no unusual activity and there is no trend for the issue.A service history review found no similar issues for the digtl centr (ref) (list number 09527-26).The xsystems centrifuge instruction guide provides adequate information regarding electrical characteristics and environmental requirements.A labeling review found the 2016 ul certification memo contains adequate information noting abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.Based upon the results of this investigation, no deficiency or malfunction of the digtl centr (ref) (list number 09527-26) was identified.

Event Description

The customer observed smoke coming from the xsystems centrifuge.The customer powered off the centrifuge and the smoke stopped.No fire was observed.There was no reported injury or impact to user safety and no impact to analytical patient results.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.

• Brand Name: X SYSTEMS CENTRIFUGE
• Type of Device: CENTRIFUGE (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5581224
• MDR Text Key: 43474074
• Report Number: 1628664-2016-00098
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09527-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1