MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDLAB 1200 SERIES 1265; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Model Number 10321852

Device Problems Break (1069); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2017

Event Type  malfunction  

Event Description

Rapid lab chemistry analyzers (x2) used for testing blood gases, lactate, and ionized calcium went down and were not available for use.Extensive troubleshooting efforts were performed without success.Lab team used a different platform in order to perform testing.Service called and service report indicates that there were multiple fluidic and electrode errors.Customer replaced measurement and wash cartridge.Replaced co-ox sample tubing, pump tubing and sample chamber.Flushed all fluidic pathways.Replaced broken aqc frame and cartridge.Found hinge pins on all three cartridge latches had worked loose and only attached on one side preventing measurement and wash cartridges from locking securely in place on the hydraulic wall.The hinge pins were reseated.The unit calibrated without error and all qc recovered within expected ranges.System was back to operational status.

• Brand Name: RAPIDLAB 1200 SERIES 1265
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 115 norwood park s; norwood MA 02062
• MDR Report Key: 7024241
• MDR Text Key: 91797672
• Report Number: 7024241
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

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
• Device Operator: No Information
• Device Model Number: 10321852
• Device Catalogue Number: 05063769
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1