MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) ACCELERATOR APS CENTRIFUGE MODULE; CENTRIFUGE MODULE FOR AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM

Catalog Number 07L02-53

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported visible sparks coming from a vent on the left side of the aps centrifuge module.The customer observed an fuc1 undervoltage error on the aps centrifuge module.When the customer reset the centrifuge, 2 loud bangs occurred, visible sparks could be seen, and a crackling sound was heard along with a smell of burning.The centrifuge was turned off and unplugged.No injuries or harm was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.Field service representative (fsr) performed troubleshooting on the automated processing system (aps) centrifuge module.The fsr discovered the hettich 5680 main electronics board was damaged.Replacement of the affected board resolved the issue.The 2020 ul certification memo contains information noting abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.A review of tracking and trending for the hettich 5680 main electronics board did not find other complaints related to the customer's issue and no trends were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the automated processing system (aps) centrifuge module or the hettich 5680 main electronics board was identified.

• Brand Name: ACCELERATOR APS CENTRIFUGE MODULE
• Type of Device: CENTRIFUGE MODULE FOR AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9953484
• MDR Text Key: 225480068
• Report Number: 3016438761-2020-00032
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

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?: Yes
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELECTRONICS BOARD, LIST 8-35003665-01; HETTICH CENTRIFUGE V3 MODEL 5680; HETTICH CENTRIFUGE V3 MODEL 5680; LIST 8-207081-01; LIST 8-207081-01, HETTICH 5680 MAIN