MAUDE Adverse Event Report: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD SAFEDRAW; SAFEDRAW SET

Catalog Number 688627

Device Problem Reset Problem (3019)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 04/17/2015

Event Type  malfunction  

Manufacturer Narrative

The batch documents were reviewed and the records showed no visual and functional problem on the batch during the manufacturing processes.The review confirmed that the operation, materials and tests were performed per the manufacturing processes.All transducers gone through electrical test and there was no indication of similar issue occurred during the manufacturing processes.The product passed and the batch was accepted and released.Further analysis was conducted on the cable connectors.On one (1) transducer cable it was observed that two pins which were very close to each other were intermittently contacting each other.The insulation heat shrink tube on one of the wire was too short and hence, not able to fully insulate the exposed wire.There is no visual and functional problem identified on the other transducer unit.Feedback and awareness from cable supplier was initiated for the effectiveness improvement action at cable connection jacket.

Event Description

The kit filled as prescribed reset to 0 and will then be in use.The patient has high blood pressure rises , and despite treatment continues to increase.In another reset of the pressure line , it is not possible to reset to 0 , and therefore be taken down.A new set is used and then seen as low blood pressure that may be given medication to get an acceptable blood pressure.

• Brand Name: SAFEDRAW
• Type of Device: SAFEDRAW SET
• Manufacturer (Section D): ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD; 198 yishun avenue 7; 76892 6; SN 768926
• Manufacturer (Section G): ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD
• Manufacturer Contact: sylvia er ; 198 yishun avenue 7
• MDR Report Key: 5537148
• MDR Text Key: 41885481
• Report Number: 8020616-2016-00018
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2016

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: Other Health Care Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 688627
• Device Lot Number: 404616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1