MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number B1434

Device Problem No Flow (2991)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported, on an unknown date, an 8" (20 cm) appx 0.49 ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer filters have been causing multiple occlusion alarms.They have tried to rectify this by changing out the filters with another lot number, but they are also causing occlusion alarms.It alarmed and occluded 15 minutes post-starting, with pressure up to 200.It alarmed; the filter was removed completely.The intravenous (iv) therapy was infusing and pressure at 75.In addition, sometimes occlusion alarm sounds before connected to the patient, and sometimes alarm sounds after it's been connected to the patient but there was no harm.The filter is connected to bd alaris tubing.To stop the alarm the filter is either removed completely from the line or the pressure setting on the pump is increased to stop the alarm with the filter remaining in line.They have their pressures set to 75 but will occasionally increase to 125 for the alarm to turn off the alarm or remove the filter completely from the line.When removed to flush the filter, the filter flushes.It sounds like it may be a pump issue, but they want to have the filters tested as well.There was no patient harm reported.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Manufacturer Narrative

The complaint of set generates unspecified occlusion alarm on item (b)(4) cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history review (dhr) for lot#5532717 was reviewed and no nonconformities were found that would have led to the reported condition on the complaint.

• Brand Name: 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17778250
• MDR Text Key: 323824387
• Report Number: 9617594-2023-00735
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: B1434
• Device Lot Number: 5532717
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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: BD ALARIS PUMP.; BD ALARIS TUBING.; UNKNOWN FLUID, UNK MFR.