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 field service engineer (fse) was on-site inspecting the centrifuge lid on an accelerator analyzer and noticed that the lid¿s gas struts were worn, which can cause the lid to fall unexpectedly, and cause a possible injury.It was noted that the fse was on-site because a different centrifuge lid had fallen on a user causing injury to the arm.However, there is no injury reported for the centrifuge in this ticket.There was no patient involvement.

Manufacturer Narrative

An abbott field service representative (fsr) was dispatched due to a centrifuge module lid that fell while the operator was performing maintenance.While on-site fixing that centrifuge module, the fsr inspected this centrifuge lid, aps cm, list number 07l02-51, serial number (b)(6), and found that the gas struts on this centrifuge module were also worn, much like the other centrifuge module, and could cause the lid to unexpectedly fall and potentially cause injury.An investigation was conducted by inpeco on the centrifuge module lid that had worn gas struts and fell while the operator was performing maintenance.Inpeco concluded the root cause is a worn out gas spring due to aging.The solution for this is to replace the worn out gas spring and several actions will be tracked through inpeco ticket #038952, including the release of co 2749 for the introduction of the new gas spring device; pn pcr0082 (gas spring) being included in the inpeco spare part catalog; and hettich confirming the intention to include additional steps and the info about the frequency of gas spring replacement in a future hettich manual.No subsequent issues have been reported.A review of the instrument history did not identify any non-conformances or deviations with the likely cause list number and complaint issue.Manufacturing documentation for the likely cause list number was reviewed and did not identify any issues.A review of labeling and historical data was done, and both were adequate, with no trends found.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 LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10714630
• MDR Text Key: 212494938
• Report Number: 3016438761-2020-00256
• 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: 11/16/2020

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: 09/25/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1