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

Catalog Number 07L07-04

Device Problem Missing Information (4053)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

A product correction letter was issued on (b)(6) 2018 to all customers with accelerator aps modules installed to inform them of the issue identified.The letter informs the customer that personnel fitted with a pacemaker/implanted heart defibrillator must not handle or work on these modules at distances less than 200 mm even if the warning label is missing.An errata sheet was included with the letter for the customer to review and save with the operations manual for future reference regarding the "safety distance" required for pacemakers/implanted heart defibrillator.An abbott representative will contact all impacted customers to schedule time to place a new hazard label on the accelerator aps modules.In the interim, the customer was instructed to remove the last page of the product correction letter and affix a copy of the label on the cover of the modules until the official pacemaker label is available.

Event Description

Field service placed a pacemaker safety label on the accelerator aps storage retrieve module, serial number (b)(4), per the mandatory technical service bulletin on (b)(6) 2018.There was no reported injury to a system operator or field service engineer.

• Brand Name: ACCELERATOR APS STORAGE RETRIEVE MODULE
• Type of Device: 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: 8205210
• MDR Text Key: 131719277
• Report Number: 1628664-2018-02204
• 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 Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 12/28/2018

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: 07L07-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1628664-09/11/18-004-C
• Patient Sequence Number: 1