MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECONDARY SET, SECURE LOCK, 34 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142290490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that, on an unknown date in june, a secondary set, secure lock, 34 inch generated a leak during patient use.The reporter stated that the setup was the primary set connected with the secondary set and spiros.It was stated that there was a disconnection between the secondary set and spiros which led to leakage.The leak site was at the level between the spiros connector and the clave cap.The event resulted in a chemo spill.The chemo spill was cleaned up as per facility protocol and the healthcare provider wore personal protective equipment/ppe.The medication involved was cisplatin with a dosage of 38 mg.There was no issue on the pump only the set.A sample is available for evaluation.There was patient involvement and no harm was reported.
Additional Manufacturer Narrative
Received one (1) used 142290490 secondary set mated to one (1) used ch2000s-c spinning spiros for inspection.The male luer of the secondary set was connected to the spiros as received.The spin feature on the used spiros was activated and spinning freely.No spline damage or shear tab anomalies on the spiros were observed.The luers were dimensionally measured and met iso specifications.The reported complaint could not be replicated or confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: SECONDARY SET, SECURE LOCK, 34 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: 19934910
• Report Number: 9615050-2024-00581
• Device Sequence Number: 7362186
• Product Code: FPA
• UDI-Device Identifier: 10887787006282
• UDI-Public: (01)10887787006282(17)261001(10)13725979
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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 Expiration Date: 10/01/2026
• Device Catalogue Number: 142290490
• Device Lot Number: 13725979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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: CISPLATIN, UNK MFR; PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SI; SPINNING SPIROS® CLOSED MALE LUER, RED CAP, LICU
• Patient Sex: Unknown