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 09/29/2021

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 observed electrical arcing/flash with clicking noise from aps centrifuge module during spin cycle.The centrifuge taken offline and powered off.There was no patient involvement and no harm to user reported.

Manufacturer Narrative

The field service representative (fsr) inspected and replaced the starting capacitor e3267 for model 4817 and 5680 (part number 8-35009891-01) and reported that centrifuge runs in manual mode were completed without issue.The replacement of part 8-35009891-01 which resolved the issue.A review of tracking and trending of the aps centrifuge module or the parts, did not identify any trends associated with the complaint issue.A review of historical data revealed no trends, systemic issues, or related nonconformances.A review of the risk reduction for safety hazards memo indicated that abbott diagnostic equipment and accessories are certified to the appropriate safety standards and the operator is protected against the spread of fire from the equipment.Further investigation was initiated by the manufacture, inpeco.The investigation reported that no deficiency was identified for the staring capacitor e3267 and no further action was required.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for either starting capacitor e3267 for model 4817 and 5680 (part number 8-35009891-01).

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12657425
• MDR Text Key: 277165373
• Report Number: 3016438761-2021-00378
• 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: 12/13/2021

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: 09/29/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/13/2021
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1