MAUDE Adverse Event Report: BECKMAN COULTER PK7300, PRE-TRANSFUSION BLOOD TESTING SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	PK7312-02
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) reported during preventive maintenance (pm) of a pk analyzer, an open flame and spark occurred from the back left side of the analyzer.No one was injured but fire extinguisher was discharged.Building was evacuated and fire department was called by the customer.Afterward, fse was able to inspect the analyzer and observed charring of print circuit board (pcb).The pcb was shorted and caused fire and spark.Fse indicated there was no evidence of leak.Additionally, the fse indicates the analyzer is retired and will be disposed.Customer will use a backup pk7300 analyzer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
Beckman field service engineer (fse) performed a preventive maintenance (pm), the fse had powered up the system after replacing pm parts and went out for a break while system initialized.The customer called fse and reported instrument sparking and observed flames.An open flame and spark occurred from the back left side of the analyzer.No one was injured but fire extinguisher was discharged by the customer.Building was evacuated and fire department was called.

• Brand Name: PK7300, PRE-TRANSFUSION BLOOD TESTING SYSTEM
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 12379069
• Report Number: 9612296-2021-00296
• Device Sequence Number: 3924342
• Product Code: JJE
• UDI-Device Identifier: 14987666535721
• UDI-Public: (01)14987666535721(11)100801
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BK060024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: Health Professional
• Device Model Number: PK7312-02
• Device Catalogue Number: N3209000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1