MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 18" (46 CM) APPX 2.5 ML, EXT SET W/PRE-PIERCED PORT, EASYDROP FLOW CONTROLLER, R; STOPCOCK, I.V. SET

Catalog Number 117420460

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

Event Description

The event occurred on an unspecified date at a veterinary clinic and involved a 18" (46 cm) appx 2.5 ml, ext set w/pre-pierced port, easydrop flow controller, rotating luer.The customer that the device delivered more lactated ringers than intended to the patient.There was no harm reported.

Manufacturer Narrative

The following sample was received from the customer and a complaint investigation was performed: 1 new list #117420460, 18" (46 cm) appx 2.5 ml, ext set w/pre-pierced port, easydrop flow controller, rotating luer; lot #4943546.There were no visual anomalies observed on the returned new flow controller set.The new flow controller set was connected to a 2 liter flexible bag of sterile water and the controller was set to 250ml per hour.The fluid through the flow controller was collected into a graduated cylinder in order to measure volume of flow through the assembly.The measured volume was 205ml per hour.The flow controller was then set to "open" and again the fluid volume was collected into a graduated cylinder.The flow of a wide open controller was 3,000ml per hour.The flow testing indicated that the device did not exceed the set volume on the dial.The complaint issue of 'delivering more than intended' was unable to be replicated or confirmed with the new flow controller set provided.

Event Description

Additional information was received from the customer on 28dec2023 indicating that the set-up was as follows: a liter bag of fluids, a primary line, a flow controller extension set connected to a t-port iv catheter in patient.The fluid expected to be left was about 700mls when the issue was noted; however, there was no fluid left in the bag.It was reported that there was no pump used as device being used were supposed to be controlling flow.It was further stated that there was no harm noted on the patient and that the patient was monitored the day following use of the device.There was no delay in therapy.

Manufacturer Narrative

Additional information can be found in d4, h4 and h10 pertaining to possible lot numbers that the customer provided since the most recent emdr submission for this particular complaint.D4 and h4 - the specific lot number of the device that was actually in use during the complaint is unknown.The customer identified two possible lot numbers: 4943546 (expiry date 08/01/2025, mfr date 07/01/2020) and 6038168 (expiry date 06/01/2027, mfr date 06/01/2022).H10: the device history records (dhrs) for the possible lot numbers 4943546 and 6038168 were reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 18" (46 CM) APPX 2.5 ML, EXT SET W/PRE-PIERCED PORT, EASYDROP FLOW CONTROLLER, R
• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15995216
• MDR Text Key: 305812146
• Report Number: 9617594-2022-00325
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 117420460
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LACTATED RINGERS, MFR UNK; LITER BAG OF UNSPECIFIED FLUIDS, MFR UNK; UNSPECIFIED PRIMARY INFUSION LINE, MFR UNK; UNSPECIFIED T-PORT IV CATHETER, MFR UNK