MAUDE Adverse Event Report: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. PMSET 1DT-XX 1SAFEDRAW(TM); DTX SAFEDRAW KIT

Catalog Number 688077

Device Problem Air Leak (1008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/30/2016

Event Type  No Answer Provided  

Event Description

When the operator inserted the safe needle into the withdraw septum air rushed into the circuit.No aspiration was carried out by the physician.They changed the set they had the same problem.The second set was from the same lot.During the incident there was a considerable loss of blood and liquid infusion has been necessary.

Manufacturer Narrative

A review of the batch documentation, which includes device history records and inspection reports, showed that no problem was found relating to damage or leakage on the reported lot number during manufacturing process.Based on records reviewed, we can confirm that all of the operations, materials and testing were properly performed on the device from the reported lots and test results show no failures or indications of a potential problem relating to damage or leakage.Visual observation was conducted to examine the two returned sample and performed the saline pressurized test at 300mmhg settings.Observed all of the ports and connection for any failures that contributed to the air ingress coming from the line when do the blood sampling process.Both samples shows no evidence of any damage or bubble built inside the fluid path and between each connection, the kit functionally performing well without failure.Analysis and evaluations were carried out on the sample to confirm and determine the root cause of the reported incident.The test setup pressurized the sample with saline liquid at 300mmhg connected to the dtx housing sensor and the other port at least 120mmhg connected through the patient line to simulate closed actual pressure inside the fluid path before conducting the insertion of the safe needle from the septum valve and observe any air coming through the system.During evaluation and verification, no leakages or damaged component observed from the returned samples.De-bubbling can still achieved since all the ports were opened in the component.Further this, the safe needle were used to simulate the condition described by the complainant using the reference syringe and the returned non-argon syringe.Upon insertion of the needle together with the attached syringe, no air goes or rushed inside the pressured line following the correct blood sampling penetration and withdrawal.No evidence of any damage septum or cracked from the component that will contribute passage of air outside the closed system.With this simulation, the two returned samples does not have any problem and functionality performing well without any failure.However, analysis and observation has been conducted and found that the used non-argon syringe can have a trap air came from the syringe due to a gap between the rubber of the plunger and the barrel container of the syringe.When performing the blood sampling withdrawal, the trap air did not came inside the fluid path with pressure instead it remains inside the syringe barrel.Based on evaluation and verification conducted, the cause of complaint as described above could not be determined.There was no functionality issue found on the returned sample and it performs the intended used of the product.It is recommended the end user to conduct thorough de-bubbling procedure stated in the ifu ¿eliminating air from the solution bag will prevent air from entering monitoring system when solution is exhausted or when bag is inverted.¿.

• Brand Name: PMSET 1DT-XX 1SAFEDRAW(TM)
• Type of Device: DTX SAFEDRAW KIT
• Manufacturer (Section D): ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.; 198 yishun ave 7; 76892 6; SN 768926
• Manufacturer (Section G): ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Manufacturer Contact: sylvia er ; 198 yishun ave 7
• MDR Report Key: 6049669
• MDR Text Key: 58133907
• Report Number: 8020616-2016-00025
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 688077
• Device Lot Number: 511297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention