MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX; ABL825

Model Number ABL825

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/03/2014

Event Type  malfunction  

Manufacturer Narrative

Data from the analyzer was received and investigated.No problems were identified based on the data logs.The event is suspected to be caused by pollution of the pco2 measurements with flush gas.This problem is very rare and is most likely due to debris in the measuring chamber such as a hair or a clot.It is not possible to identify this type of problem in calibration data, since the calibration measurements are performed on gas.This is why the calibration has not shown any irregularities.The analyzer was brought back to the local radiometer service office where the following actions were performed.The measuring chamber was replaced and furthermore pump rotor type a and type b were replaced.Gas valves have been cleaned and the membranes have been replaced electrode channel for pco2 has been checked and was ok.At last the pco2 electrode was replaced.After these activities the analyzer showed no problems during calibration and qc measurements.The analyzer will now be re-installed at the customer's site.Info regarding if this problem has been observed previously has been requested.Also a status from the customer regarding the performance of the analyzer, after a couple of weeks in function has been requested.

Event Description

The customer reported about significant deviations of pco2 results from the same pt within a short period of time.Same pt: on (b)(6) 2014 at 11.23 - pco2 result of 43.5mmhg; (b)(6) 2014 at 11.29 - pco2 result of 94.4mmhg.Results from other parameters also varied significantly between the measurements.The physician did not trust the suspicious results, and the results were therefore not used clinically.No injury or maltreatment resulted from this case.

• Brand Name: ABL800 FLEX
• Type of Device: ABL825
• Manufacturer (Section D): RADIOMETER MEDICAL APS; bronshoj 2700 ; DA 2700
• Manufacturer Contact: akandevej 21; bronshoj 2700 ; 8273827
• MDR Report Key: 4001336
• MDR Text Key: 49673015
• Report Number: 3002807968-2014-00022
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2014

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: Health Professional
• Device Model Number: ABL825
• Device Catalogue Number: 393-826
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1