MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO CONNECTOR

Model Number D1000

Device Problems Air Leak (1008); Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

Pending receipt of devices.

Event Description

Int'l.(b)(6) complaint received reporting air in line with unspecified dialysis set-ups where d1000 tego connectors were in use.The initial information received reports ".In three instances with three separate patients; air was observed being pulled into the circuit through tego cap." the tego connectors were removed and replaced.There were no reported patient injuries, change in baseline condition and or adverse consequences.Additional event, device usage information as well as return status of the involved devices although requested has not been received.

Manufacturer Narrative

Device return: two used d1000 tego connectors were returned.Visual inspection (pre and post decontamination) of the as received tego connectors recorded blood between the body and the seal.Engineering pressure testing and analysis was performed.The results recorded both units leaked/failed seal integrity.Each of the tego connectors were than disassembled and the internal componentry evaluated.The report documented both tego units had damages/cuts to the one piece seal at the main seal interface.This condition could result in internal leakage.Corrective and preventative actions: a detailed analysis of the tego design, materials, manufacturing and inspection processes and equipment was performed.The data and engineering efforts identified the seal component anomaly was attributable to the manufacturing /molding operation involving a cavity core pin edge.Corrective actions have been identified, qualified and implemented.Additionally icu medical has initiated and is recalling those lots that could potentially contain this condition.

Event Description

Int'l.((b)(6)) complaint received reporting air in line with unspecified dialysis set-ups where d1000 tego connectors were in use.The initial information received reports ".In three instances with three separate patients; air was observed being pulled into the circuit through tego cap." the tego connectors were removed and replaced.There were no reported patient injuries, change in baseline condition and or adverse consequences.Additional event, device usage information although requested has not been received.This is the mfs'.Follow up report to provide additional information and device return investigation results.

• Brand Name: TEGO CONNECTOR
• Type of Device: TEGO CONNECTOR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6080759
• MDR Text Key: 59225645
• Report Number: 2025816-2016-00104
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: 3275467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Removal/Correction Number: 2025816-09/01/2016-005-R
• Patient Sequence Number: 1