MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 1.2 MICRON FILTER, SECURE LOCK, 119 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1955488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is not available to be returned for evaluation; however, photos were provided and awaiting evaluation.Additional contact: (b)(6).
Event or Problem Description
The event involved a primary plum set, 1.2 micron filter, secure lock, 119 inch and occurred on an unspecified date.The report states that the filter and line leaking where filter is in the middle of the line.The leak occur near the circle areas on the blue filter.Total parenteral nutrition is being infused (lipids, dextrose, amino acid solutions) and line was infusing to patient when leaks occurred.No adverse harm but disruption to patient care.The total parenteral nutrition bag must be discarded as it cannot be respiked.The patient then has no nutrition for up to 24 hours as the tpn bag is customized for the individual patient and a new bag cannot be received until a new one is ordered and delivered.Therapy cannot be resumed until a new bag of tpn is provided.Tpn bag cannot be respiked with a new filter as tpn bag is not designed to have multiple spikes.No hole, cut, tears or any defect observed prior to using the filter.No harm was reported.
Additional Manufacturer Narrative
Photos provided showing the set in the packaging and out of packaging.No damages or anomalies noted.No samples were returned for investigation.The reported complaint could not be confirmed on the 195540488 primary plum set.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record for lot 13487633 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: PRIMARY PLUM SET, 1.2 MICRON FILTER, SECURE LOCK, 119 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17330960
• Report Number: 9615050-2023-00248
• Device Sequence Number: 12666043
• Product Code: FPA
• UDI-Device Identifier: 10887787008774
• UDI-Public: (01)10887787008774(17)260101(10)13487633
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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 Expiration Date: 01/01/2026
• Device Model Number: 1955488
• Device Catalogue Number: 195540488
• Device Lot Number: 13487633
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/16/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: TOTAL PARENTERAL NUTRITION, MFR UNK
• Patient Sex: Unknown