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

Catalog Number 07L02-51

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed the springs holding up the centrifuge lid failing on the aps centrifuge (ln 7l02).If the lid is left unsupported, the springs fail and the lid crashed down.The lid fell on the customers arm, but no injury occurred and no medical treatment was sought.

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.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The gas springs that hold the automated processing system (aps) centrifuge modules lid in the upright position failed and could not support the lids weight.The lid dropped onto the customers arm, no injury occurred.The field service representative decontaminated the module and replaced the worn gas spring with another identical component to resolve the issue.Based on all available information and abbott diagnostics' complaint investigation 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 MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7797283
• MDR Text Key: 117604365
• Report Number: 1628664-2018-01502
• 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: 12/11/2018

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: 07/24/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1