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

Catalog Number 07L02-53

Device Problem Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

The customer observed electrical spark/arcing after spin cycle from aps centrifuge module.The centrifuge was taken offline and powered off.There was no patient involvement and no harm to user reported.No additional impact to user safety was reported.

Manufacturer Narrative

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

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 replacement of the relay temporarily resolved the issue.The fsr then replaced the relay a second time, along with the starting capacitor e3267 for model 4817 and 5680 (8-35009891-01) and running capacitor e3268 for model 4817 and 5680 (8-35009892-01).This resolved the issue completely and the module functioned as intended.A review of the risk reduction for safety hazards memo indicates abbott diagnostic equipment and accessories are certified to the appropriate safety standards and the operator is protected against electric shock and the 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 starting capacitor e3267 for model 4817 and 5680 and running capacitor e3268 for model 4817 and 5680 was identified.

Event Description

The customer observed electrical spark/arcing after spin cycle from aps centrifuge module.The centrifuge was taken offline and powered off.There was no patient involvement and no harm to user reported.No additional impact to user safety was reported.

• Brand Name: ACCELERATOR APS CENTRIFUGE MODULE
• Type of Device: CENTRIFUGE MODULE FOR AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17081800
• MDR Text Key: 316930274
• Report Number: 3016438761-2023-00308
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1