MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP CENTRIFUGE MODULE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06Q03-01

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, glp centrifuge module, list number 06q03-01, which has a same/similar component of the modular glp systems track registered in the us, list number 04z96-51.Note: the glp systems track is not yet marketed in the us.

Event Description

The customer reported the circuit boards of the glp centrifuge module blew upon first use.The customer observed charring and a large area of scorching on both circuit boards.No impact to patient management or user safety reported.

Manufacturer Narrative

The complaint investigation for the glp centrifuge module¿s centrifuge frequency conv failing and found with charring with a large area of scorching on both circuit boards included information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.The boards were shipped to the supplier for further investigation and found the affected converter boards that were received arrived without any thermal paste, which can lead to overheating.This was determined the most likely cause of the issue and was resolved through replacement.Labeling was reviewed and provides adequate information regarding providing field service the procedure to ensure adequate heat conducting paste is covering the base plate and to properly install the centrifuge frequency converter within the glp centrifuge module.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any non-conformances or potential non-conformances related to the issue.Based on the investigation, no systemic issue or deficiency for the glp centrifuge module or centrifuge frequency conv was identified.

• Brand Name: GLP CENTRIFUGE MODULE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer (Section G): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16478830
• MDR Text Key: 310614157
• Report Number: 3023268435-2023-00011
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K213486
• 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: 04/11/2023

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: 06Q03-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1