MAUDE Adverse Event Report: BECKMAN COULTER, INC AU5800 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU5800

Device Problems Charred (1086); Fire (1245); Smoking (1585); Arcing (2583); Sparking (2595); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

The bec fse (field service engineer) found a damaged wire harness under the photometry unit.The wire was melted and charred.The fse believes the wire shorted and made contact with the frame and conducted electrically to the pcbs; resulting in damage.The fse performed repair on the analyzer.The analyzer could not be restored to operation and a new analyzer will be provided to the customer.(b)(4).

Event Description

On the (b)(6) 2016 while carrying out service on an au5800 clinical chemistry analyzer, the fse reported an electrical surge occurred resulting in burned and damaged pcbs (printed circuit boards).The fse ( field service engineer) stated that they observed flames from two (2) pcbs and smoke from the analyser.The flames lasted approximately four (4) seconds.There were no erroneous results generated due to this event.The fire was self-extinguished.No injuries or exposure was reported and the fire department was not called.

Manufacturer Narrative

Four (4) damaged printed circuit boards (pcb) were returned to the manufacturer.The most likely cause of the damaged printed circuit boards was incorrect setup of the 24vdc power supply.Our manufacturing site believes that the fse (field service engineer) most likely made an error in the connection of the poles (positive and negative) when he replaced the 24vdc power supply directly prior to this event.This caused a backward/reverse voltage and thus the damage to the printed circuit boards observed.His scenario was reproduced by our manufacturing failure analysis team.(b)(4).

• Brand Name: AU5800 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER, INC; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino,; nagaizumi-cho sunto-gun; schizuoka,, mishima JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: david davis ; 250 s, kraemer blvd.; m/s e1 .se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 5643945
• MDR Text Key: 44831894
• Report Number: 9612296-2016-00065
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU5800
• Device Catalogue Number: B23281
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability