MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO

Model Number D1000

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

Involved device discarded.

Event Description

Int'l.((b)(6)) complaint received reporting air leakage issues with unspecified dialysis set-up where d1000 tego connectors were in use.The initial information received reports the event as follows "machine alarmed with air leak detected.Leak identified in the tego bung, micro air bubbles were noticed in the translucency between the yellow window on the hub.It was a significant bubble and when the tego was changed over the machine resumed operation normally and the problem resolved.Tego discarded due to blood contamination.New device from same lot number provided to send back for testing." additional event/usage information as well as same lot sample return status although requested has not been provided as of the date of this report.

Manufacturer Narrative

Device return: two pkg./unused tego connectors from same lot# 3275469 were returned.Although requested the involved mating and access devices were not returned.Engineering testing and analysis to the applicable product specification was performed.The results recorded both same lot sample tego connectors passed the acceptance criteria.

Event Description

Int'l.((b)(6)) complaint received reporting air leakage issues with unspecified dialysis set-up where d1000 tego connectors were in use.The initial information received reports the event as follows ".Machine alarmed with air leak detected.Leak identified in the tego bung, micro air bubbles were noticed in the translucency between the yellow window on the hub.It was a significant bubble and when the tego was changed over the machine resumed operation normally and the problem resolved.Tego discarded due to blood contamination.New device from same lot number provided to send back for testing.".Additional event/usage information as well as same lot sample return status although requested has not been provided as of the date of this report.This is the mfgers.Follow up report to provide additional information and device return investigation findings.

• Brand Name: TEGO
• Type of Device: TEGO
• 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: 6329574
• MDR Text Key: 67385212
• Report Number: 2025816-2016-00326
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• 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: 3275469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1