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

Catalog Number 07L02-03

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

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

Event Date 01/29/2014

Event Type  malfunction  

Event Description

The customer stated that the accelerator aps centrifuge was not operational and they noticed a burning smell.Field service was dispatched and discovered a burnt component on the main a1 board.There was no report of injury.

Manufacturer Narrative

(b)(4).The centrifuge on the accelerator aps was not operational and there was a burning smell.There was no visible flame, smoke, or sparks.Field service found a burnt component on the main centrifuge board and replaced it.Review of the service history for the module showed no previous tickets indicating a failure of the main centrifuge board, nor any other issues that may have contributed to the failure.Customer complaint data was reviewed and no adverse trends were identified.The accelerator aps operations manual was reviewed and was found to adequately address the issue.Operators are advised on the elements of electrical safety and precautions to observe for safe operation.The information suggests a malfunction of the main electronic board occurred that prevented the centrifuge from functioning as intended.The issue was resolved by field service replacing the board according to standard troubleshooting procedures.The investigation did not identify a deficiency.

Manufacturer Narrative

Field service found a burned r100 component on the main electronics board, part number 8-206623-01.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 8-206623-01 and 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.From centrifuge to centrifuge module for automated sample handling and processing system; product code from jqz to jqp 11.Added concomitant: board main electronic; part number 8-206623-01.

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)(4), determined that the issue is from the r100 component of the hettich centrifuge board which was too small to withstand a current spike.Hettich 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: 3633069
• MDR Text Key: 3987633
• Report Number: 1628664-2014-00026
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2016

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: Health Professional
• Device Catalogue Number: 07L02-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2016; 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1