MAUDE Adverse Event Report: SYSMEX RA CO. LTD. SYSMEX CA-620; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number CA-620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

The sample tube (bd 1.8ml double walled tube) used for analysis was unacceptable for use on the analyzer.The sample probe was hitting the side of the tube while aspirating.No analyzer deficiencies were identified.Per the instructions for use (ifu) for the analyzer, the only double walled tubes to be used on the analyzer are the vacutainer plus plastic citrate tube, 2.7 ml or the vacuette sandwich coagulation tube, 3.0 ml/3.5ml.The ifu specifically identifies the tube used as not being acceptable for use on the analyzer.

Event Description

A sample was collected from a patient receiving coumadin treatment in an unapproved sample collection tube.The user performed analysis with the unapproved tube.The initial prothrombin time (pt) result was "no coag", meaning no clot was formed and no results could be generated.The next analysis was a prothrombin time extended (ptx) which also resulted as "no coag".The ptx was repeated and gave a result of 159.4 seconds.This result was reported to the clinician.The clinician administered vitamin k to the patient.The entire clinical picture for the patient is unknown.The patient was redrawn several days later and returned a pt result of 25.6 seconds which correlates with the patient's clinical picture.The user reported this value in a corrected report of the initial value.The patient did not suffer any harm due to the vitamin k.

• Brand Name: SYSMEX CA-620
• Type of Device: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer (Section G): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer Contact: peter shearstone ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 6912819
• MDR Text Key: 88107227
• Report Number: 1000515253-2017-00034
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: CA-620
• Device Catalogue Number: CK978289
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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): Other