MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500E BLOOD GAS SYSTEM; RP 500E

Model Number	11416751
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the patient sample clotted their rp500e analyzer and therefore a blood gas result could not be obtained during a code.The patient died.Safety data information from the complaint states that the customer is not alleging that the cause was related to an instrument malfunction or harm to the patient was due to the use of the device.
Additional Manufacturer Narrative
The customer stated that the same sample was used on this and another rp00e instrument and clotted both.The instrument event log shows multiple obstruction errors.Siemens has requested more information and instrument log files for further investigation.This mdr is being filed out of an abundance of caution due to the information from the customer stating that the patient is deceased.
Additional Manufacturer Narrative
Siemens has shown due diligence in attempting to receive more information from the customer however, the customer has not been able to provide the requested information.Instrument log files were not returned and therefore no further investigation can be performed.The customer did state that the cause of the clot was due to the use of a non-heparinized syringe.The customer is not alleging that the rp500e instrument caused or contributed to the death of the patient.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Common Device Name: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 13563733
• Report Number: 3002637618-2022-00010
• Device Sequence Number: 5848685
• Product Code: CHL
• UDI-Device Identifier: 00630414286143
• UDI-Public: 00630414286143
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K192240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11416751
• Device Catalogue Number: 11416751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown