MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, SECURE LOCK, 129 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	15244-28
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a primary plum set, clave secondary port, 2 clave y-sites, secure lock, 129 inch where it was reported that the patient was on norepinephrine, when the charge nurse attended to pump there was an alarm reading ¿back prime, air in line.¿ the nurse back primed using a syringe but cassette failed when resetting.Nurse opened the cassette and checked for air in line, but cassette failed again.The nurse was unable to troubleshoot error on the pump.There was patient involved, unknown human harm and unknown delay in critical therapy.This report captures 2 occurrences.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of 'cassette failed' could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, SECURE LOCK, 129 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19262958
• Report Number: 9615050-2024-00364
• Device Sequence Number: 2581985
• Product Code: FPA
• UDI-Device Identifier: 00887709102453
• UDI-Public: 00887709102453
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 15244-28
• Device Lot Number: UNKNOWN
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NOREPINEPHRINE, UNK MFR.; UNSPECIFIED INFUSION PUMP, UNK MFR.
• Patient Sex: Unknown