MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 08H67-01

Device Problems Charred (1086); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

Abbott field service was called to the customer site to replace the cell-dyn ruby analyzer's closed mode of operation sample processor motor assembly (with pulley; part number 8921294801).The analyzer was having probe homing failures in the closed mode of operations.After installing the part and powering on the analyzer, the issue recurred.The probe home sensor was then inspected and found to be corroded.Also, field service observed burnt components on the sample handler module, which were attributed to have been caused by a leak in the system.Replacements parts were ordered.There are no reports of injury or any evidence of damage to the surrounding lab environment.No impact to any patient management was reported.

Manufacturer Narrative

An abbott field service representative (fsr) visited the customer site to inspct the cell-dyn ruby analyzer.While investigating the cause of instrument errorr code 1109 (close mode needle unable to reach home) the fsr discovered burnt components on the sample handler module.The fsr attributed this to a leak within the instrument system.The fsr replaced several hardware components to resolve the issue.Subsequent instrument operations and test results were acceptable.Several parts were returned to aid in the investigation of this issue.The examination of these parts revealed the following: the components u16 and u17 on the field returned pcb assy, shm, cdruby, ln: 8960229002 were found to be burnt.The u16 (stepper motor driver integrated circuitry or ic ) is used to control the solenoid assy, block ii, 24vdc, cd3200, ln: 8921260501 via the cable assy, shm1-gs2 solenoid, cdruby ln: 8952208501 that is connected to j13 of the shm pcb assy.Two interface connectors on cable assy, shm1-gs2 solenoid, cdruby ln: 8952208501 and solenoid assy, block ii, +24vdc, cd3200 ln: 8921260501 had been contaminated by the leaking fluid as indicated by a green stain.The electrical short between two wires on the interface connectors may have caused the u16 overcurrent and became "burnt "due to the excessive heat dissipation.The u17 on the shm pcb assy may also have been "burnt" because of it sharing the +24vdc power supply with u16.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The cell-dyn ruby system operator's manual contains information to address the current customer issue.The event was specific to the cell-dyn ruby analyzer, serial number (b)(4), and the stated likely cause parts (list numbers 8960229002, 8921260501and 8952208501) due to electrical components having come into contact with some (unidentified) liquid.Based on the available information from the customer site and the results of this evaluation, there is no evidence to reasonably suggest that a systemic issue or product deficiency exists.Concomitant medical products : assy, hemoglobin flow cell, cd ruby, rohs ln: 8921292202 cable assy, shm1-sprcsr sensor, cd ruby ln: 8952208701 pcb assy, shm, cd ruby ln: 8960229002 solenoid assy, block ii, 24 vdc, cd3200 ln: 8921260501 cable assy, shm1-gs2 solenoid, cd ruby.

• Brand Name: CELL-DYN RUBY ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• 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: 7038790
• MDR Text Key: 93063749
• Report Number: 2919069-2017-00157
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1