MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 5.9 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CH3128
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The event occurred on an unknown date involving a 30" (76 cm) appx 5.9 ml, 20 drop admin set w/integrated chemoclave® drip chamber, 0.2 micron filter, spiros® w/red cap, hanger where it leaked doxorubicin + etoposide + vincristine in 0.9% sodium chloride from the filter area onto the top of iv pump.The tubing was replaced or restrung and bag rehung and finished.There was patient involvement and no patient harm.This is the first of three events.
Additional Manufacturer Narrative
Received one used.List #ch3128, 30" (76 cm) appx 5.9 ml, 20 drop admin set w/integrated chemoclave® drip chamber, 0.2 micron filter, spiros® w/red cap, hanger; lot #8409834.Also received one used.List #unknown, 0.9% nacl 100ml bag; lot #uso11853.The complaint of leakage can be confirmed on the returned device.As received the outlet filter on the used sample was wetted out with prior infusate.No other anomalies noted.The returned set was primed, and leak tested.There was a leak observed from the outlet filter on the used sample.The probable cause of leakage is a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 30" (76 CM) APPX 5.9 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBER
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16216199
• Report Number: 9617594-2023-00030
• Device Sequence Number: 20331306
• Product Code: ONB
• UDI-Device Identifier: 00840619024802
• UDI-Public: (01)00840619024802(17)270801(10)8409834
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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 Model Number: CH3128
• Device Catalogue Number: CH3128
• Device Lot Number: 8409834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: 0.9% NACL, MFR UNK; DOXORUBICIN, MFR UNK; ETOPOSIDE, MFR UNK; VINCRISTINE, MFR UNK
• Patient Sex: Unknown