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

Catalog Number 07L02

Device Problems Detachment Of Device Component (1104); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A product correction letter was issued to customers instructing them to limit the maximum centrifuge speed to 3500 rpms, maintain the one-foot safety perimeter around the centrifuge as outlined in labelling, visually inspect the centrifuge buckets for cracks and replace if cracks are observed or if the "useable until" date has expired, and to continue to perform weekly maintenance per the accelerator aps operations manual.

Event Description

Cracks in the accelerator aps centrifuge buckets were identified upon inspection.The buckets were replaced.There was no report of user injury or impact to patient results/management.

• 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
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5765339
• MDR Text Key: 49293010
• Report Number: 1628664-2016-00184
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 07/01/2016

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1