MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE® CLEAR, R; STOPCOCK, I.V. SET

Model Number MC33892

Device Problem Inaccurate Delivery (2339)

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

Event Date 01/27/2022

Event Type  malfunction  

Event Description

The event involved a 107" (272 cm) appx 8.7 ml, transfer set w/dual check valve, microclave® clear, rotating luer which was reported to have over-infused.The customer reported that the patient's closed medication set infused 250ml of normal saline into patient between 2200 on (b)(6) 2022 and 0500 on (b)(6) 2022.Based on the patient medication schedule, the patient should have only received 60ml of normal saline between those times.A pump was not used with the set.There was patient involvement, however, no harm was reported as a consequence of this event.The patient condition is stable.This event did not prolong the patient's hospitalization.

Manufacturer Narrative

One used list #mc33892, 107" (272 cm) appx 8.7 ml, transfer set w/dual check valve, microclave® clear, rotating luer; lot #5711361, one used list #unknown, 1ml syringe; lot #unknown, and one used list #unknown, 0.9% nacl 250ml bag; lot #y380331 were received for evaluation.A used mc33892 transfer set was returned connected to a 0.9% nacl 250ml bag at the proximal bag spike with a 1cc luer lock syringe connected to the microclave at the proximal end of the check valve.There were no visual anomalies observed.The used mc33892 transfer set was removed from the 250ml bag of 0.9% sodium chloride and water was easily drawn from a reservoir into a syringe connected to the microclave on the check valve.The complaint states there was no pump used during infusion.The water was able to be discharged from the syringe through the infusion line to the distal end of the transfer set without occlusion or difficulty.The used mc33892 transfer set was pressure leak tested to test both bond integrity and check valve functionality.There were no leaks at any location along the fluid path and the check valves performed as designed without back flow or leakage.The complaint was regarding over delivery of medication.There are no controls or means within the mc33892 transfer set that would result in an over delivery.The complaint was unable to be confirmed.The used mc33892 transfer set met product performance expectations.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional telephone number: (b)(6).

• Brand Name: 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE® CLEAR, 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: 13624776
• MDR Text Key: 290188961
• Report Number: 9617594-2022-00031
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709070790
• UDI-Public: (01)00887709070790(17)261101(10)5711361
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33892
• Device Catalogue Number: MC33892
• Device Lot Number: 5711361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• 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: NORMAL SALINE, MFR UNK