MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS ANALYZER; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Obtain Sample (2533)

Patient Problem No Information (3190)

Event Date 04/26/2019

Event Type  malfunction  

Event Description

Patient required 3 heel sticks and one arterial stick to obtain a point-of-care test of potassium level.The rapidpoint in the nursery rejected 4 samples due to insufficient sample volume and/or sample not detected.The sample which was rejected for sample not detected was subsequently successfully analyzed on the rapidpoint in picu.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; point of care - business unit; 2 edgewater drive; norwood MA 02062
• MDR Report Key: 8586052
• MDR Text Key: 144265490
• Report Number: 8586052
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 DA