MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO ASPIRATOR

Model Number	956-622
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, false high na results were obtained from the abl800 analyzer when using the safepico aspirator, lot ym-01.When using a different lot of the sampler, the problem didn't appear at all.No patients were involved.
Additional Manufacturer Narrative
In this case the root cause was not identified: production documentation for two heparin batches has been checked but no abnormalities were found.There were also no deviations in laboratory journal reporting final test for samplers 956-622 ym-01 & heparin.Reference and defective samples were tested for electrolytes content and all results were within specification.Received defective samples were also tested on water based solution and whole blood.The conclusions from the tests of the defective samples are that reported issue couldn't be recreated during the tests.No preventive actions were implemented directly as a result of this complaint.Several counter measures (control points) are already built into the samplers' production process: raw paper tests for electrolytes content before release for heparin production.Heparinized paper tests for electrolytes content and heparin activity before release for samplers' production process.Final control of samplers including heparin activity - after ready product's sterilization and before release for client.

• Brand Name: SAFEPICO ASPIRATOR
• Common Device Name: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 6800066
• Report Number: 3002807968-2017-00026
• Device Sequence Number: 10961254
• Product Code: JKA
• UDI-Device Identifier: 05700699566225
• UDI-Public: (01)05700699566225(17)190502(10)YM01
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2019
• Device Model Number: 956-622
• Device Catalogue Number: 956-622
• Device Lot Number: YM-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 09/13/2017; 01/03/2018
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/12/2017; 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1