MAUDE Adverse Event Report: BECKMAN COULTER BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM; SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY

Model Number PK7312-03

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

The customer reported diluted detergent leaked from the beckman coulter pk7300 automated microplate system.The customer did not specify the volume of the leak, but indicated that the leak was not contained within the instrument and diluted detergent leaked onto the floor of the laboratory.The customer was wearing personal protective equipment consisting of gloves and a laboratory coat at the time of the event and no injury or direct exposure to the leak was reported.No erroneous results were generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

Additional initial reporter information from section e1 of this report: the customer's telephone number is 44-0161-251 4206.A field service engineer (fse) was dispatched to the customer's site.The fse evaluated the instrument and determined that the cause of the leak is attributed to a defective detergent pump.The fse replaced the detergent pump to resolve the issue and verified the repair as per established procedures.(b)(4).

• Brand Name: BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM
• Type of Device: SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho; sunto-gun, shizuoka, jp-nota 411- 0931; JA 411-0931
• Manufacturer Contact: dung nguyen ; 250 s. kraemer boulevard; brea, CA 92821 ; 7149614941
• MDR Report Key: 3662029
• MDR Text Key: 4287570
• Report Number: 9612296-2014-00044
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: BK090036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PK7312-03
• Device Catalogue Number: N3209100
• Other Device ID Number: SW VERSION 6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2011
• 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