MAUDE Adverse Event Report: BECKMAN COULTER MISHIMA K.K. OLYMPUS PK7300 AUTOMATED BLOOD BANK ANALYZER; SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY

Model Number	PK7312-02
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement in this event.A bec (beckman coulter) fse (field service engineer) was dispatched to the customer's laboratory to assess instrument performance.Upon visual inspection the fse identified a damaged wire which was sparking and smoking.The wire was rubbing up against a metal plate within the instrument.The fse was able to repair the damaged wire and re-secure it in place to prevent friction with the metal plate.In conclusion, a malfunction of the wire is the cause of the sparking and smoking.No one was injured by either the spark or the smoke.Service intervention was able to correct the issue.
Event or Problem Description
The customer reported obtaining multiple error messages on the laboratory's olympus pk7300 automated blood bank analyzer (serial number (b)(4)).Both "reagent transfer pitch motor errors" and "reagent transfer for/back motor errors" were obtained.There was no patient sample involved in this event, therefore there was no change to or impact to patient treatment in conjunction with this event.A bec (beckman coulter) fse (field service engineer) was dispatched to the customer's laboratory to assess instrument performance.

• Brand Name: OLYMPUS PK7300 AUTOMATED BLOOD BANK ANALYZER
• Common Device Name: SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY
• Manufacturer (Section D): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho, sunto-gun; shizuka, 411-0 931; JA 411-0931
• MDR Report Key: 7235726
• Report Number: 9612296-2018-00013
• Device Sequence Number: 882509
• Product Code: KSZ
• UDI-Device Identifier: 14987666535721
• UDI-Public: (01)14987666535721(11)121101
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BK070030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Service Personnel
• Device Model Number: PK7312-02
• Device Catalogue Number: N3209000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1