MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ADMIN SET W/20 DROP IN-LINE CHAMBER, CHEMOLOCK W/RED CAP, SPIROS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3361
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	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been received.Testing and investigation are not yet complete.Concomitant medical products: vidaza (manufacturer unknown), low sorbing tubing alaris pump infusion set (ref#: 10013072, alaris), 20 gauge x 0.75 inch miniloc safety infusion set (ref#: 0632034, bard), neutron cap (ref#: 12595-01, icu medical), spiros (ref#: ch2000s-c, icu medical), unspecified alaris pump.
Event or Problem Description
The event involved an administration set w/20 drop in-line chamber, chemolock w/red cap, spiros that resulted in a chemo spill of 15 ml of vidaza.The leak was noticed at the spiros connection.The patient had a 250 ml bag of normal saline attached to a low sorbing tubing alaris pump infusion set, which was attached to the miniloc safety infusion set by a neutron cap and a spiros cap.The device was attached to the port above the alaris pump.There was patient involvement and a delay of therapy, but no reported adverse event.No additional information was provided.
Additional Manufacturer Narrative
One (1) used full w/ vidaza 241 mg in 50ml 0.9% nacl injection usp, one (1) used, list # cl3361, 42" (107 cm) appx 5.2 ml, admin set w/20 drop in-line chamber, chemolock w/red cap, spiros, bag hanger, drop-in red cap, lot # 3858032, one (1) used, smartsite infusion set by carefusion {spiked into one (1) used, full 0.9% nacl injection usp bag}, one (1) used, spinning spiros list # & lot # unknown was received for investigation.The two spiros assemblies, one connected to an intermediate y-port on a carefusion set and the other attached to the distal end of the set, were pressure leak tested as part of that assembly and separate from the assembly.There was no leakage observed at any location along the fluid path or with either of the two spiros.The complaint of leakage was unable to be confirmed.The dhr for lot 3858032 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: ADMIN SET W/20 DROP IN-LINE CHAMBER, CHEMOLOCK W/RED CAP, SPIROS
• 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: 8286889
• Report Number: 9617594-2019-00023
• Device Sequence Number: 11297906
• Product Code: ONB
• UDI-Device Identifier: 00887709071407
• UDI-Public: (01)00887709071407(17)231101(10)3858032
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 11/01/2023
• Device Model Number: CL3361
• Device Catalogue Number: CL3361
• Device Lot Number: 3858032
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1