MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265 BLOOD GAS ANALYZER; RL 1265

Catalog Number 10321852

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 12/16/2016

Event Type  Death  

Manufacturer Narrative

The customer contacted siemens on 07 mar 2017 and on 08 mar 2017 a siemens field engineer was dispatched to the hospital.Upon arrival he found that the rl1265 was operational.He replaced the coox module components and sent them to siemens for evaluation.After the components were replaced, he ran a qc and it passed.He also processed several patient samples without errors.The instrument was fully operational.A visual inspection of the returned coox module components indicated that there were no issues.The coox module was installed on an internal siemens rapidlab 1265 and tested for four days.The assembly performed as expected and there were no issues with qc recoveries or blood specimens.The instrument files that were provided to siemens did not correlate to the time the event occurred so they did not provide any additional information.They were for the time period between 05 feb 2017 and 14 feb 2017.Instrument data files for the time of the event (december 2016) were not available.Discussions with the customer indicate that the patient was doing very poorly and not having thb available on the rl1265 made no difference to the outcome of the patient.They also indicated that the rl1265 did not cause or contribute to the death of the patient.They got thb results for the patient every half hour from the lab (on a different analyzer).Based on siemens investigation into this event and the information siemens was able to obtain from the customer, the indication is that the rapidlab 1265 instrument was operating as intended and no further investigation can be conducted.

Event Description

The customer indicated that the rapidlab 1265 (rl1265) instrument reported a d70_2 error message (system fails a co-ox optical clarity test) for thb.The customer then mentioned that a case is in the coroner's court due to the thb being unavailable, a patient bleed was missed.The customer indicated that the patient was doing very poorly and not having thb available on the rl1265 made no difference to the outcome of the patient.They also indicated that the rl1265 did not cause or contributed to the death of the patient.They got thb results for the patient every half hour from the lab (on a different analyzer).

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Type of Device: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 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: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6461498
• MDR Text Key: 71763437
• Report Number: 3002637618-2017-00061
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death