MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2H8480
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the spike of clearlink system non dehp solution set slipped out half way from the 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag which resulted in a leak.This was identified during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.It was observed, the components were correctly placed and according to specifications.Functional testing was performed, including clear passage and pressure testing.And the device performed according to product specifications.During testing, the spike of the returned device was connected to an exactamix ethylene-vinyl acetate (eva) bag and a bag of sterile water and there was no issue noted.A priming test was also performed, and there were no issues noted.The reported condition was not verified.A batch review was conducted, and there were no deviations found related to this reported condition, during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11349307
• Report Number: 1416980-2021-00746
• Device Sequence Number: 16980194
• Product Code: FPA
• UDI-Device Identifier: 00085412048499
• UDI-Public: (01)00085412048499
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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
• Operator of Device: Other
• Device Catalogue Number: 2H8480
• Device Lot Number: R20G09051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1000 ML TPN BAG; 1000 ML TPN BAG