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

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

It is unknown at this time if the device will be returning for evaluation.

Event 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.

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 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.

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,
• Type of Device: 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
• MDR Text Key: 131496517
• Report Number: 9617594-2018-00229
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709013025
• UDI-Public: (01)00887709013025(17)230901(10)3790169
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: B9126
• Device Lot Number: 3790169
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1L SODIUM CHLORIDE, MFR UNK