MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 18" (46 CM) 150 ML BURETTE SET (MICROCLAVE, NO SHUT-OFF VALVE) W/VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 124250460

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

One used list# 124250460, 18" (46 cm) 150 ml burette set (microclave®, no shut-off valve) w/vented cap (lot# 4097093) was received and visually inspected.As received, the tubing was separated from the bottom cap of the burette.Uv solvent was present on both separated components.The dimensions of the separated tubing was measured and found to meet design specifications.The probable cause of the tubing separation is unknown.The reported complaint of micro-air in the line could not be replicated or confirmed.A device history review for lot# 4097093 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

Event Description

The event involved a ndehp clv inline burette 150 that was reported to introduce micro-air into the perfusion system on the heart lung machine while infusing an unspecified custodial fluid.This required constant pressure to be applied to it (via a pressure bag) to keep it at bay.There was patient involvement but no harm, adverse event, and no delay in therapy reported.

• Brand Name: 18" (46 CM) 150 ML BURETTE SET (MICROCLAVE, NO SHUT-OFF VALVE) W/VENTED CAP
• 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: 10895428
• MDR Text Key: 240334971
• Report Number: 9617594-2020-00516
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709090866
• UDI-Public: (01)00887709090866(17)240501(10)4097093
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2020

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 Expiration Date: 05/01/2024
• Device Catalogue Number: 124250460
• Device Lot Number: 4097093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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