MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ACCELERATOR APS CENTRIFUGE MODULE; CENTRIFUGE MODULE FOR AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM

Catalog Number 07L02-02

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

Field service found a damaged r100 component on the main electronics board, part number 8-35003665-01.The board was replaced to resolve the issue.The accelerator aps operations manual and the centrifuge operations manual were reviewed.Troubleshooting and safety information is provided.Customer complaint data was reviewed and an increase in failures for the main electronics board, part 8-35003665-01, triggered an alert which suggests an adverse trend.Based on this information, a product deficiency was identified and further investigation is being performed.A follow-up report will be submitted at the completion of the investigation.(b)(4).

Event Description

The centrifuge for the accelerator automated processing systems (aps) became non-responsive.An abbott field service engineer (fse) was dispatched.The fse replaced the hettich 5680 main electronics board to resolve the issue.A damaged r100 component on the board was observed.There was no impact to patient management or user safety reported.

Manufacturer Narrative

A product deficiency was identified due to an increase in complaints for failures of the r100 component of the main electronics board (parts 8-35003665-01 and 8-206623-01).The supplier, (b)(6), determined that the issue is from the r100 component of the (b)(6) centrifuge board which was too small to withstand a current spike.(b)(6) released an enhanced main board revision 06 with a different r100 resistor.It is considered acceptable to continue using the automation system because the issue does not impact operator nor patient safety.The accelerator aps operations manual and the centrifuge operations manual were reviewed and show that troubleshooting and safety information is provided.There have been no reported injuries for this issue.If the electrical components of the main electronics board fail, it will shut down the centrifuge module.If the centrifuge shuts down, the operator will receive an error message.The frequency of this hazard was assessed and it was determined that though there was a trend in complaints, the overall frequency of low had not changed from the predicted frequency as outlined in the risk management file.

• Brand Name: ACCELERATOR APS CENTRIFUGE MODULE
• Type of Device: CENTRIFUGE MODULE FOR AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM
• 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: 5493695
• MDR Text Key: 40275382
• Report Number: 1628664-2016-00066
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07L02-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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