MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS®; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3931
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Testing is not complete.
Event or Problem Description
The event involved a 8.5" (22 cm) appx 1.0 ml, ext set w/microclave® clear, chemolock¿ port, spiros® w/red cap, clamp, that when administering melphalan to a hospital inpatient, via an unspecified pump, leaking was discovered coming from the backside of the chemolock port where it is bonded on the y-site of the extension set.The tubing set up was the line was primed with saline from the rescue line, and then attached to the patient.The clinician did not prime at the chemolock port.The extension set had been in use for 1 hour and the leak was noted when the clinician checked on the patient at 8am.There was only a small amount of leakage before it was caught.It was reported that the chemotherapy medication came in contact with the patient and the clinician.The patient was washed with soap and water and the spill was cleaned up per facility protocol.The extension set was replaced but the drug was not replaced since there was 100-125ml left of a 1000ml infusion when the leak occurred.As the leak was not from the bag side (that chemolock attachment was patent) the chemolock extension set was replaced and the remainder of the drug was infused without incident.There were no defects noted.There was patient involvement, no adverse event, no harm was done as a result of the reported event, no blood loss or bleed back, and no delay in therapy.
Additional Manufacturer Narrative
H10 - one used cl3931, ext set w/microclave clear, chemolock port, spiros w/red cap, clamp (lot# 4172961) was received and visually inspected.As received, a slight slit propagation was seen on the top surface of the microclave seal.No other damage or anomalies were identified.No mating devices were returned.The cl3931 set was hydrostatic pressure leak tested according to product performance specifications.Leakage occurred from the distal end of the chemolock port while it was in the unactivated state.During testing, the chemolock port was manually pulled from the bond pocket of the y-connector with little effort.Some solvent was identified on the post of the chemolock port and within the bond pocket.The reported complaint of leakage was confirmed.The leak occurred at the interface between the post of the chemolock port and the bond pocket of the y-connector.The probable cause of the leak is due to an error in the manual bonding process during manufacturing.A device history review (dhr) for lot# 4172961 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, 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: 9634266
• Report Number: 9617594-2020-00022
• Device Sequence Number: 14087032
• Product Code: ONB
• UDI-Device Identifier: 00887709077201
• UDI-Public: (01)00887709077201(17)240701(10)4172961
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/08/2020

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: 07/01/2024
• Device Model Number: CL3931
• Device Catalogue Number: CL3931
• Device Lot Number: 4172961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MELPHALAN, UNK MFR; UNSPECIFIED PUMP, UNK MFR