MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, CLAVE Y-SITE, 100 INCH, NON-DEHP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	B91780490
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional phone # (b)(6).The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event involved a primary set, clave y-site, 100 inch, non-dehp where the customer reported that the infusion pump used with the set continued to infuse after the bag of medication ran out, infusing approximately 5 ml of air into the patient.The rn on duty was able to use a syringe to pull out the 5 ml of air.Additionally, the customer stated that they are not sure on what was defective.They ran the pump and the tubing set through testing and couldn't recreate the issue that happened.The testing of the pump and tubing set all passed inspections.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
Received one (1) used list #unknown plum set.As received no damage or anomalies were observed.The primary plum set was attached to an icu medical-provided intravenous (iv) bag, primed per packaging directions, and a test infusion was performed.No cassette errors, occlusion alarms, or air-in-line alarms were generated and no restrictions in flow were noted.In attempts to replicate clinical use a delivery accuracy test was performed.The delivery was found to have a percent error of less than 1%.A leak test was also performed per specifications.No leakage was observed.Additionally, the infusion test was repeated however air was introduced into the line simulating a bag running out.The pump alarmed as expected.The complaint of over delivery cannot be confirmed.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PRIMARY SET, CLAVE Y-SITE, 100 INCH, NON-DEHP
• 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: 20320304
• Report Number: 9615050-2024-00714
• Device Sequence Number: 7669380
• Product Code: FPA
• UDI-Device Identifier: 10887787009276
• UDI-Public: 10887787009276
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K142367
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: B91780490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PLUM 360 (L#300100483 S#(B)(6)), ICU MEDICAL; SYRINGE, MFR UNK
• Patient Sex: Unknown