MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MEDIANE - 173 CM (68") EXT SET W/4 GANG STOPCOCK W/6 MICROCLAVE CLEAR, POLE MOU; PRIMARY IV SET

Catalog Number 011-MC330420

Device Problem Backflow (1064)

Patient Problems Overdose (1988); No Consequences Or Impact To Patient (2199)

Event Date 08/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The customer reported a mediane, 173 cm (68") ext set w/4 gang stopcock w/6 microclave® clear, pole mount, 4-way stopcock that had an issue of the patient¿s infusion not passing due to a clamped midline.After unclamping, the infusion was permeable.The nurse the g5% 1000cc pouch was inflated and the iv heparin infusion was flowing at 6.5ml/h with no pressure alarm sounding.After control of heparinemia, the nurse noticed a significant overdose in heparin caused by a probable rise in heparin in the g5% bag despite the non-return valves.The entire tubing system was changed.There was patient involvement with a reported adverse event, however, no harm or blood loss was reported.Additionally, there was no change in the patient status after the event nor prolonged hospitalization.

Manufacturer Narrative

D10: the device was received for evaluation on september 24, 2020.H10: one (1) list# 011-mc330420 used mediane ext set w/4 gang stopcock w/6 microclave® clear, pole mount, 4-way stopcock connected to one (1) used extension set, manufacturer unknown and one (1) bd syringe 60 ml were received and visually inspected on september 24, 2020.As received, no damage or anomalies were identified.The connected extension sets returned were leak tested.No leaks were seen.The functionality of each stopcock was then tested.The handles were rotated in all open flow positions and shut off positions.The product met performance expectations.No backflow or leakage was observed during testing.The reported complaint cannot be confirmed.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.

• Brand Name: MEDIANE - 173 CM (68") EXT SET W/4 GANG STOPCOCK W/6 MICROCLAVE CLEAR, POLE MOU
• Type of Device: PRIMARY 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
• MDR Report Key: 10536440
• MDR Text Key: 207017487
• Report Number: 9617594-2020-00400
• Device Sequence Number: 1
• Product Code: FMG
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC330420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1