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, IV SET

Catalog Number	B1434
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 8" (20 cm) appx 0.49 ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer.The reporter stated that their iv filters have been causing multiple occlusion alarms.They have tried to rectify this by changing out the filters, but they are also causing occlusion alarms.The pump alarmed and occluded 20 minutes after attaching to the baby.They tried to increase the pressure to 100, and it alarmed after one minute.When not attached to the baby, it alarmed as pressure went up.They took the filter offline, there was no alarm and pressure was low.Additional information was received stating that sometimes occlusion alarm sounds before connected to the patient, sometimes alarm sounds after it's been connected to the patient.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.The customer stated that it may be a pump issue, but they want to have the filters tested as well.There was patient involvement, however, harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it is yet to be completed.
Additional Manufacturer Narrative
The complaint of occlusion alarm on item b1434 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 was conducted and no non conformities were found that would have led 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
• Common Device Name: STOPCOCK, IV 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: 17764492
• Report Number: 9617594-2023-00725
• Device Sequence Number: 6664250
• Product Code: FMG
• UDI-Device Identifier: 00887709001657
• UDI-Public: (01)00887709001657(17)280401(10)13610908
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: B1434
• Device Lot Number: 13610908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 12/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALARIS PUMP, BD; ALARIS TUBING, MFR BD
• Patient Sex: Unknown