MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SET PRIMARIO 2 CANALES C/ CLAVE SIN DEHP; ADMINISTRATION SET

Model Number	1253828
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return to the manufacturer for testing and investigation.
Event or Problem Description
The event involved a customer report stating that when connecting the syringe to the y-clave connection on the plum set, the membrane did not return to its original position, which caused bleed-back to the exterior.A cap was used in the y-connection to stop the blood flow.Blood was noted in the patient's bed.The set was in use for two days with saline solution.The customer stated that no one was harmed as a result of the event.
Additional Manufacturer Narrative
The date the device was returned to manufacturer was july 8, 2019.Received one used list # 125380428 was returned with the complaint of the seal in the y-clave failing to return to its original position after removing a syringe.The syringe was not returned for evaluation.As received, the set was air pressure leak tested according to product specifications and no leaks were detected anywhere along the fluid path.The cassette of the returned set was inserted into an icu medical provided plum 360 pump and a test infusion was ran per product specifications.No alarms sounded and the test completed successfully.The complaint indicates a possible stickdown at the distal y-clave, therefore the y-clave was disassembled and blood residuals were noted in and on the seal and spike.The seal presented with tear down its side and top.The spike showed no evidence of damage.The reported complaint can be confirmed.The source of the axial rupture to the seal is not known.A batch record review was performed to lot# 906485h, list# 12538-0428 and no discrepancies that may have contributed to a complaint of this nature were found.

• Brand Name: SET PRIMARIO 2 CANALES C/ CLAVE SIN DEHP
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8736353
• Report Number: 9615050-2019-00207
• Device Sequence Number: 2572270
• Product Code: FPA
• UDI-Device Identifier: 10887787006671
• UDI-Public: (01)10887787006671(17)210601(10)906485H
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K141789
• 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): 06/04/2019

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: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 1253828
• Device Catalogue Number: 125380428
• Device Lot Number: 906485H
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1