MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER,; STOPCOCK, I.V. SET

Catalog Number	B9126
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown at this time if the device will be returning for evaluation.
Event or Problem Description
The event occurred on an unspecified date.The event involved a primary set that the customer reported, as they adjust the flow rate of the solution, the velocity of the solution that passes into the tubing increases without touching the control.It was also reported that it was adjusted to a low rate but it increases alone, resulting in the patient receiving more than the expected unspecified solution.There was no report of patient harm.No additional information was provided.
Additional Manufacturer Narrative
It was unknown if the device was returning for evaluation.There were no samples, videos, or photographs returned for investigation.A probable cause cannot be identified based on the information that has been provided.The device history review (dhr) for lot 3790169 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.
Event or Problem Description
Additional information received from the customer that the solution involved was 1l sodium chloride.There was no adverse event.It was also stated that the nurse was able to react immediately when the event was noticed and corrected the flow rate and adjusted it by hand.It was also added that 9 instances of this issue occurred with the same patient on this day.
Additional Manufacturer Narrative
H10 - received one new, list # b9126,100" (254 cm) appx 12.8 ml, 15 drop primary set w/3 microclave¿, rotating luer, filter cap for testing an evaluation on 2/11/2019.The infusion set was tested for drop rate control of the roller clamp after a short infusion.The infusion set roller clamp was able to control drip rate over the 1 to 2 minutes that the customer stated was the duration of infusion during use.The infusion set roller clamp performed as expected and as designed.Additional information can be found in section d10 and h3.

• Brand Name: 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, 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: 8186303
• Report Number: 9617594-2018-00229
• Device Sequence Number: 11268841
• Product Code: FMG
• UDI-Device Identifier: 00887709013025
• UDI-Public: (01)00887709013025(17)230901(10)3790169
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2018

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: 09/01/2023
• Device Catalogue Number: B9126
• Device Lot Number: 3790169
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 02/25/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/14/2019; 02/28/2019
• 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: 1L SODIUM CHLORIDE, MFR UNK