MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE DRIP CHAMBE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) new list# ch3011, 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemoclave® drip chamber, spiros® w/red cap, bag hanger.Lot# 4734249 was received and visually inspected.As received, no damage or anomalies were identified.No used product was returned.The set was leak tested and leakage occurred from the spiros in the area of the o-ring/poppet interface at gravity pressure while in the unactivated position.No leaks were observed in the activated position or from any other location on the set.The reported complaint of leaking from the spiros can be confirmed.The probable cause of the leaking spiros is due to a molding anomaly on the sealing surface of the poppet sub-component.A device history review for lot# 4734249 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
The event involves a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemoclave® drip chamber, spiros® w/red cap, bag hanger that leaks an unspecified hazardous drug from the tubing out of the spiros after they have primed the line with fluid.This results in exposure to hazardous material and wasted product to remake the dose.The solution infused was made by b.Braun medical.The solution bag was spiked with tubing at the port, then the tubing was primed with the normal saline solution prior to addition of the drug.The leak is typically not noticed until after compounding with the unspecified medication.There was no patient involvement.This report captures the second of three events.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE DRIP CHAMBE
• 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
• MDR Report Key: 10358875
• Report Number: 9617594-2020-00283
• Device Sequence Number: 950908
• Product Code: ONB
• UDI-Device Identifier: 00840619023966
• UDI-Public: (01)00840619023966(17)250201(10)4734249
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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: 02/01/2025
• Device Catalogue Number: CH3011
• Device Lot Number: 4734249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1