MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	MC9079
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.Without the returned device, a probable cause is unable to be determined.(b)(6).
Event or Problem Description
A medsun mandatory medwatch report was received that stated, ¿pt had blood backing up the line (did not get to the filter) in evening, caught by rn when she came to assess pts dressing.She flushed the line to remove the blood back up and resolved issue.30 minutes later, blood backup up again, per parents pt was crying very hard after dressing had been reinforced.Attempted to use gravity to return blood, however was not returning.Flushed line again at main line and blood cleared.Blood had also backed up to the other side of the bifurcate up to where the medline was clamped, attempted to flush this side, but would not flush.Clamped it back off.And with the assistance of break nurse, changed out bifurcate and medline using strerile procedure.As the main ivf tubing was not compromised this was connected to the new bifurcate.When the main ivf tubing was disconnected from the old bifurcate air appeared in the lower portion of the line up to the level of the filter.All of this air was removed from the line by opening the clamp to the free flow before reconnecting the line to the patient.Sterile procedure was observed throughout".The event occurred in the patient¿s room at the hospital.There was patient involvement and no patient harm was reported.
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The reported complaint cannot be confirmed based on the information that has been provided.The device history record (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.
Event or Problem Description
Additional information was received as follows: ¿it was reported that the air was not being detected in the pump.".

• Brand Name: 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 11454445
• Report Number: 9617594-2021-00073
• Device Sequence Number: 14465363
• Product Code: FMG
• UDI-Device Identifier: 00887709078161
• UDI-Public: (01)00887709078161(17)250801(10)4961948
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: Health Professional
• Device Expiration Date: 08/01/2025
• Device Model Number: MC9079
• Device Catalogue Number: MC9079
• Device Lot Number: 4961948
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 DA