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

Catalog Number 07L02-51

Device Problems Unintended Movement (3026); Device Fell (4014)

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 stated that the lid fell down on the accelerator aps centrifuge module while a user was performing maintenance.The lid did not cause any injury to a user, but the customer is concerned that the heavy lid could potentially cause injury if it were to fall down again.It was identified that the gas springs were no longer holding the lid up as expected due to age (approximately 10 years).No patient involvement.

Manufacturer Narrative

Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.An investigation was conducted by inpeco for the centrifuge module lid.Inpeco concluded the root cause was a worn out gas spring due to aging.The solution for this issue is to replace the worn out gas spring.Several actions will be tracked through inpeco including the introduction of a new gas spring device and the intention to include additional steps and information about the frequency of gas spring replacement in a future version of the operator's manual.Based on the investigation and all available information, no product deficiency 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; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10690351
• MDR Text Key: 211720736
• Report Number: 3016438761-2020-00250
• 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: 11/05/2020

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: 07L02-51
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1