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U.S. Department of Health and Human Services

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

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ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. PMSET 1DT-XX 1SAFEDRAW(TM) Back to Search Results
Catalog Number 688077
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2016
Event Type  malfunction  
Manufacturer Narrative
A follow up report shall be submitted once the investigation is completed.
 
Event Description
Safedraw set (part no 688077) was found leaking inside an infant's cot. Saline had been found leaking onto the cot sheets, the leak suspected to be from the transducer. The used set was available for us to inspect, however the set packaging had been discarded. The current unopened set on the storeroom shelf were from lot number: 509544, therefore there is a possibility that this set may have come from the same lot number.
 
Manufacturer Narrative
Visual observation on the returned sample showed that no damage or any leakage was observed on the component received. The batch documents have been reviewed and the records showed that no damage was found relating to damage assembly and/or leakage during the manufacturing process. The review confirmed that all the operations, materials and tests were performed per manufacturing procedures. There is no indication of similar issue occurred during the manufacturing process. The kit assembly was assembled in according to specification and documented in (b)(6) 2015. Analysis and evaluations have been carried out to confirm and determine the root cause to the reported leakage in the system. The returned device was pressurized with saline at 300mmhg for 24 hours, the result shows that no fluid leakage was found during the testing which unable to determine the cause of leakages. Simulation and test were provided on the returned samples in the inventory using similar stopcock and by turning to 45 degree position, leakage was observed after few hours of testing. With the lever at position less than or more than the 45 degree positions, leakage was observed within 5 minutes of testing. Further detail analysis and evaluations were carried out on the structure and design of the stopcock, including turning the lever to different positions, the evaluation results had the similar observation above that is when the lever is not at the exact 45 degree position and unintended position of the stopcock; leakage can be seen within short period of time. In the ¿instruction for use¿ for the pressure monitoring kits, a warning statement indicates that stopcock lever must be positioned at 90° for ¿off¿ position. Do not position them at 45° to achieve an ¿off¿ position as this is imprecise and may result in contamination, leaked, bleed back or air embolism. Based on the analysis, simulation, and evaluation, the root cause of leakage reported could not be determine as all of the connection and ports have no damage or cracked component. Likely the potential cause of leakages complaint is that when the end user unintendedly put the lever of the stopcock at 45 degree causing a leaked from the component. The user is advised to follow the ifu warning statement which indicates that stopcock lever must be positioned at 90° for ¿off¿ position. Do not position them at 45° to achieve an ¿off¿ position as this is imprecise and may result in contamination, leaked, bleed back or air embolism.
 
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Brand NamePMSET 1DT-XX 1SAFEDRAW(TM)
Type of DeviceSAFEDRAW
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 Key5471988
MDR Text Key39690909
Report Number8020616-2016-00007
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K935782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue Number688077
Device Lot Number509544
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/01/2016 Patient Sequence Number: 1
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