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 CHEMOLOCK DRIP CHAMBER,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.The investigation is pending.
Event or Problem Description
The event involves a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemolock¿ drip chamber, spiros® w/red cap, hanger that had a chemo spill from the spiros end on the tubing.The medication used was not specified.No additional information is available.
Additional Manufacturer Narrative
H10: one (1) used list # cl3011, 30" (76 cm) appx 3.3 ml, 20 drop admin set (lot # 4868079) connected to the y-smartsite of one (1) bd pump set, one (1) used partially full 10ml syringe, 0.9% nacl by excelsior medical, two (2) icu medical 100 ml nacl containers, and one (1) used unknown safety infusion needle ext set were received and visually inspected.As received, the returned devices appeared to be securely connected.No visible damage or anomalies were observed.The connected devices were primed with water at gravity pressure and leak tested.Leakage occurred from the o-ring/poppet interface of the spinning spiros included on the cl3011 set.No leaks were seen from any of the mating devices returned.The reported complaint 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.The device history review for lot number 4868079 was reviewed and there were no relevant non-conformances found.Additional information in h7.The list and lot number of the device was identified as part of a voluntary recall.Icu medical is notifying affected customers via a letter requiring removal of the affected products from the market.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK 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
• MDR Report Key: 10508301
• Report Number: 9617594-2020-00371
• Device Sequence Number: 19591423
• Product Code: ONB
• UDI-Device Identifier: 00887709057012
• UDI-Public: (01)00887709057012(17)250601(10)4868079
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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: 06/01/2025
• Device Model Number: CL3011
• Device Catalogue Number: CL3011
• Device Lot Number: 4868079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1