MAUDE Adverse Event Report: IRRAS USA INC. IRRAFLOW SYSTEM; TUBING

Model Number TUBE SET 2.0

Device Problem Mechanical Problem (1384)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

This issue occurred while treating a 47 year old female patient for ivh.Patient irraflow control unit was alarming for a high icp and not draining.The nurse was trouble shooting the situation and noted that roller clamp on the drainage line was in the open position-but sticking in place and not open all the way-impeding flow.When she tried to fix roller clamp the roller on the clamp, and then popped off.The tubing drainage then flowed, bringing down the icp, however the tubing clamp issue also created a minor delay in treatment.No further information was provided except that the remaining treatment was uneventful.Product return has been requested.

Event Description

This issue occurred while treating a 47 year old female patient for ivh.Patient irraflow control unit was alarming for a high icp and not draining.The nurse was trouble shooting the situation and noted that roller clamp on the drainage line was in the open position-but sticking in place and not open all the way-impeding flow.When she tried to fix roller clamp the roller on the clamp, and then popped off.The tubing drainage then flowed, bringing down the icp, however the tubing clamp issue also created a minor delay in treatment.No further information was provided except that the remaining treatement was uneventful.Product return has been requested.This follow up report is being made to provide the results of the irras complaint investigation: the tube set, lot # 1009748 was shipped from cdh via rma23-022 to a contracted decontamination facility, and then shipped to irras south where it was received on 03/23/2023.The tube set was inspected for any damage.The roller clamp was inspected.It was noted that the roller was missing, as reported by the customer.The tubing was inspected and found to be deformed at the roller position.The drainage tubing is specified to have an od of 5.56mm; the deformed portion of the tubing was measured and the od was 4.48mm.The investigation results confirmed the complaint issue was due to use error, having used the tube set longer than the required 5 days, causing deformation of the tubing which may have contributed to the impedance of the drainage flow.The roller clamp may have had excessive force applied to it by the nurse, and combined with the deformed tubing, allowed it to disengage (pop off) more easily.The associated documents will be included in the complaint process as part of the documented activity for the investigation.The investigation and functional testing confirmed that the roller clamp issue is attributed to use error along with clinical use of the tube set beyond its intended use both of which contributed to the customer experience as documented in the complaint.A review of the lot history record (lhr) of the tube set, 1009748, shows that: o the tube set was assembled according to irras' approved contract manufacturer (cm) second source medical (ssm) validated manufacturing processes.O no manufacturing nonconformances were identified it is irras' assessment that the tube set was functioning as intended at the time of treatment.

• Brand Name: IRRAFLOW SYSTEM
• Type of Device: TUBING
• Manufacturer (Section D): IRRAS USA INC.; 11975 el camino real; suite 304; san diego CA 92130
• Manufacturer (Section G): IRRAS USA INC; 11975 el camino real; suite 304; san diego 92130
• Manufacturer Contact: jeanne warner ; 11975 el camino real; suite 304; san diego 92130
• MDR Report Key: 16671126
• MDR Text Key: 313192244
• Report Number: 3013508628-2023-00002
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TUBE SET 2.0
• Device Catalogue Number: ICDS 020
• Device Lot Number: 1009748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female