MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" EXT SET, 0.2 MICRON FILTER, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	B1181
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Testing and investigation are not yet complete.
Event or Problem Description
The customer reported a 8" ext set, 0.2 micron filter leaked during 24 hour infusion of chemotherapy.The filter was placed at 11:05 on (b)(6) 2020 and the leak was noticed at 20:15 on (b)(6) 2020.The chemotherapy medications were doxorubicin, etoposide, and vincristine.The site of the leak was around the circle piece of the filter.There was patient involvement, but no harm reported.The nursing staff were aware of the risk of the filter leaking and put plastic between the patient's skin and the filter.The customer reported no alarms were going off/on the unspecified iv pump during the event.The pump was set to alarm at 6 psi (pounds per square inch).
Additional Manufacturer Narrative
H10: one (1) used list# b1181, 8" ext set, 0.2 micron filter, rotating luer (lot# 4400035) connected to one (1) spinning spiros was received and visually inspected.As received, the 0.2 micron filter of the b1181 extension set was saturated with prior infusate solution.The device was leak tested and leakage was observed from the filter of the extension set.The leakage occurred through multiple locations of the vent material on the 0.2 micron filter.This is due to wetting (saturating) of the vent material by the infusate solution during use.The probable cause is a temporary or permanent loss of the hydrophobic properties due to the infusate interaction with the vent material during use.A device history review for lot# 4400035 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 8" EXT SET, 0.2 MICRON FILTER, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• 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: 9829861
• Report Number: 9617594-2020-00068
• Device Sequence Number: 19017720
• Product Code: FMG
• UDI-Device Identifier: 00887709000667
• UDI-Public: (01)00887709000667(17)241001(10)4400035
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 10/01/2024
• Device Model Number: B1181
• Device Catalogue Number: B1181
• Device Lot Number: 4400035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: DOXORUBICIN, MFR UNK; ETOPOSIDE, MFR UNK; UNSP INFUSION PUMP; VINCRISTINE, MFR UNK