MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC330523
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.The device history record was reviewed and there were no relevant non-conformances were identified that would have contributed to the reported complaint.If the device is returned in the future, or if additional information is received, then a supplemental emdr will be submitted containing the pertinent information.
Event or Problem Description
The complaint involved a 127" (323 cm) appx 9.7 ml, transfer set w/microclave® clear, dual check valve, smallbore clear/pur yellow trifuse ext set w/2 microclave® clear (yellow, green rings), 2-0.2 micron filters, rotating luer.It was reported that the patient's fluid lines (down to clave) were changed, and drops were flowing through the tip of line.The pump was functioning well.The fluid line was connected to the patient (a baby), and a slight amount of blood backed up in the picc (peripherally inserted catheter) due to a loss of pressure while cleansing the line and while waiting for reconnection.The lines were connected, and then the rn (registered nurse) assisted with holding for x-ray and blood was still backing up in picc line that was closest to baby.The transport nurse was requested to assess the line, and was then also unable to flush.Picc line removal/reinsertion was required.There was fluid (tpn) present on the floor after the complaint/issue was discovered; however, a crack or leak in the lines was not identified.The picc assessment was good throughout the shift.The registered nurse threw away the old lines.The baby's blood glucose remained stable throughout the event, but the staff was unable to re-hang the tpn (total parental nutrition) for the patient.There was no harm as a result of this complaint/issue.

• Brand Name: 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18126962
• Report Number: 9617594-2023-00979
• Device Sequence Number: 18037632
• Product Code: FPA
• UDI-Device Identifier: 00887709092020
• UDI-Public: (01)00887709092020(17)270101(10)5773174
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2023

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 Catalogue Number: MC330523
• Device Lot Number: 5773174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TPN (TOTAL PARENTERAL NUTRITION), MFR UNK; UNSPECIFIED INFUSION PUMP, MFR UNK; UNSPECIFIED PICC LINE, MFR UNK
• Patient Sex: Unknown