MAUDE Adverse Event Report: BECKMAN COULTER FC 500 MPL FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number UPS (MPL)

Device Problem Sharp Edges (4013)

Patient Problem Head Injury (1879)

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 the field serivce engineer went to the (b)(6) medical centre and received stitches on his forehead.The progress of the healing was monitored by the medical center and the stitches were removed after the wound healed.He had gone to the customer site to address fluctuations on flow check whcih he attributed to unstable laboratory temprature.Bec internal identifier (b)(4).

Event Description

During a retrospective review of service records, it was found that the field service engineer (fse) servicing the customer's fc500 flow cytometer instrument (service request (b)(4)).While accessing the flowcell to perform alignments, the fse had the front cover open on the analyzer, he stood up in the process and bumped his head against the front cover corner of the instrument and cut his forehead.The injury took place on (b)(6) 2016.At the time of the occurrence, the fse removed his gloves and washed his forehead wound thoroughly and proceeded to use his own emergency medical kit to address the bleeding.He also informed his supervisor of the injury.The fse confirmed that there was no direct exposure to hazardous materials as the result fo this event.

• Brand Name: FC 500 MPL FLOW CYTOMETER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea FL 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3107520824
• MDR Report Key: 7845003
• MDR Text Key: 119152296
• Report Number: 1061932-2018-00034
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590572822
• UDI-Public: (01)15099590572822(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K071681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UPS (MPL)
• Device Catalogue Number: 626554
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other