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

Catalog Number 07L02-53

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2017

Event Type  malfunction  

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, inpeco, determined that the issue is from the r100 component of the (b)(4) centrifuge board which was too small to withstand a current spike.(b)(4) 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.

Event Description

The customer observed power failure on the centrifuge module.Abbott field service replaced the main electronics board which resolved the issue.The r100 portion of the board shows damage only.There was no personal injury, impact to patient management, or facility damage reported.

• 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: 6743581
• MDR Text Key: 81154770
• Report Number: 1628664-2017-00294
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 07/26/2017

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: 07L02-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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