MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PFA-100 SYSTEM

Model Number	PFA-100 SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The customer's pfa-100 system had been giving vacuum test failure messages.The customer replaced the system o-ring and primed the catridges and vacuum cup.The discordant results were obtained after these actions had been performed.The customer has requested for a loaner system and is planning to send their pfa-100 system for repairs.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely elevated platelet function assay collagen-epinephrine (pfa col epi) result and a discordant, falsely low platelet function assay collagen-adenosine diphosphate (pfa col adp) result were obtained on a patient sample on a pfa-100 system.The discordant results were reported to the physician(s).The sample was repeated for pfa col epi and pfa col adp on an alternate pfa-100 system.The pfa col epi recovered lower and the pfa col adp recovered higher.There are no known reports of patient intervention or adverse health consequences due to the discordant pfa col epi and pfa col adp results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2021-00058 on 16-aug-2021.Additional information (03-nov-2021): the customer's pfa-100 system was sent to siemens for repairs.Siemens service performed a preventative maintenance, lubricated the syringe, replaced the carousel cover, anti-reflective pads, parking seal, vacuum o-ring, and trigger/air tubing, and verified the tc sensor and the trigger dispense tube alignment.Siemens performed 430 loop test cycles with no failures.The system was operational after being returned to the customer.Siemens identified that the customer was not using a new cleaning pad each time they performed a system self-test.As per the pfa-100 system instruction manual, when performing the self-test, "always use a new vacuum test cup and a new cleaning pad." the cause of the event was a use error.Sections h3 and h6 were updated to reflect the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: PFA-100 SYSTEM
• Common Device Name: PFA-100 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; registration number: 300360107; am kronberger hang 3; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 12328589
• Report Number: 9610806-2021-00058
• Device Sequence Number: 3964608
• Product Code: JOZ
• UDI-Device Identifier: 00842768024870
• UDI-Public: 00842768024870
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K060489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: PFA-100 SYSTEM
• Device Catalogue Number: 10444868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female