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 Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

Field service found a burned 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 customer stated that they smelled a burning odor coming from the centrifuge module.The customer took the module offline and the smell stopped.There was no observed smoke or fire.There was no impact to patient management, user safety, or facility damage reported.The abbott field service engineer (fse) replaced the hettich 5680 main electronics board to resolve the issue.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from accelerator aps centrifuge module, list number 07l02-03, serial number (b)(4) and manufacturing site to accelerator aps centrifuge module, list number 07l02-03, serial number (b)(4), manufacturing site of (b)(4).Mdr number 1628664-2016-00115 has been submitted and all further information will be documented under that mdr number.Mdr submitted against the incorrect serial number.

• 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: 5570429
• MDR Text Key: 42622546
• Report Number: 1628664-2016-00090
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• 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?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: No
• 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