MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC X-SYSTEMS CENTRIFUGE (DIGITAL)

Catalog Number 09527-26

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer reports smoke coming from the x-systems centrifuge accompanied by a foul odor.There are no injuries reported or damage to the surrounding lab environment.There is no patient involvement indicated in this event.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).

Manufacturer Narrative

An abbott field service engineer (fse) replaced the xsystems centrifuge that was observed smoking and the new unit functioned as intended.There were no returns made available from the customer site.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.A review of the service history for the architect i2000sr analyzer, serial number (b)(4), was performed and the search returned no additional service or complaint tickets related to visible smoke coming from the xsystems centrifuge (list number 09527-26) or other issues with the centrifuge.The xsystems centrifuge instruction guide provides information to address the current customer issue.Based on the results of the current investigation, no product malfunction was identified.Device manufacture date refers to the date of the architect i2000sr analyzer.

• Brand Name: X-SYSTEMS CENTRIFUGE (DIGITAL)
• Type of Device: CENTRIFUGE
• 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 ; 847937-512
• MDR Report Key: 3718337
• MDR Text Key: 4227700
• Report Number: 1628664-2014-00065
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/20/2014

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 Catalogue Number: 09527-26
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 04/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN: (B)(4); SN: (B)(4); ARCHITECT I2000SR ANALYZER LN: 03M74-02; ARCHITECT I2000SR ANALYZER LN: 03M74-02