MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MC100

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problems Hypoglycemia (1912); Chemical Exposure (2570)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The event involved a microclave¿ clear neutral connector.It was reported that a child had tpb infusing to broviac, the parent informed nursing staff that the line was disconnected as well as the cap from the broviac.Nursing performed emergency line care.The impact of the incident is that the emergency line care was done, a cap change was performed and the patient was started on d101/2ns+20 meq kcl/l but had low blood sugars for the same and needed regular fluid titration throughout the night to correct it.The disconnection happened at the microclav cap that was attached directly to the broviac line distal to the pump (proximal to the patient).¿the broviac was free bleeding¿ for an unknown amount of time.The patient soaked through the right side of his child size hospital gown and on to the soaker pad.They unfortunately did not weight the items so don¿t know a specific amount.Patient¿s hemoglobin dropped from 92 to 83 from the event.It took a week for him to get back to the low 90¿s for the hemoglobin.There was patient involvement and no adverse event was reported.

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

• Brand Name: MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18023053
• MDR Text Key: 326751466
• Report Number: 9617594-2023-00890
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2023

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: MC100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BROVIAC , MFR UNK; D101/2NS+20 MEQ KCL, MFR UNK; TOTAL PARENTERAL NUTRITION, MFR UNK