MAUDE Adverse Event Report: BREA DISCRETE MFG IO HSCA, END USER ACCURATE DIAGNOSTICS; RADIOASSAY, VITAMIN B12

Model Number HSCA, END USER ACCURATE DIAGNOSTICS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injury (2348)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

Beckman coulter complaint handling unit evaluated the issue with the power express product, (b)(6) end user accurate diagnostics.The customer reported that water had leaked under the stockyard causing an employee to slip and fall.The employee was injured and is attending physical therapy.There was no exposure to open wounds or mucous membranes.The failure mode was condensation escaping from the putty seal on the stockyard.The issue was resolved by applying putty to reseal the wiring seal to stop the leak.Service monitored the system operation and observed no leakage or issues.(b)(6).The beckman coulter internal reference identifier is (b)(4).

Event Description

The customer reported that water had leaked under the stockyard on their custom power express automation line, causing an employee to slip and fall.The manager stated that the employee took a few days off work and is currently leaving work early to attend physical therapy.Per consultation with fse and automation technical support, it is unknown what caused the condensation to escape from the putty seal.The fse resealed the putty position to stop the leak.He cleared the water spots and placed additional paper towels where the leak occurred to ensure the leak had stopped.Fse monitored the system for one (1) hour and no condensation formed at the putty.A follow-up service visit was created for additional inspection.During the follow up visit, it was observed the condensation had leaked from the stockyard.The fse applied putty around the areas that had leaked.Fse verified that the leaking had stopped and monitored operation for over two (2) hours with no issues observed.

• Brand Name: HSCA, END USER ACCURATE DIAGNOSTICS
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BREA DISCRETE MFG IO; 250 s kraemer blvd; brea CA 92821 8000
• Manufacturer (Section G): BREA DISCRETE MFG IO; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; brea, CA 92821-8000
• MDR Report Key: 8781424
• MDR Text Key: 150732763
• Report Number: 2050012-2019-01086
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Public: (01)NOT-FOUND(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090588
• 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
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HSCA, END USER ACCURATE DIAGNOSTICS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/13/2019
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other