MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING; STOPCOCK, I.V. SET

Model Number AM6109

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Sepsis (2067)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

D4 - lot # possible lots with d4 - expiration date and h4 - device mfg date: 11001834 (exp date of 10/01/2027 and mfg date of 10/01/2022).6042707 (exp date of 08/01/2027and mfg date of 08/01/2022).The customer also provided a possible lot number of 6403894 but this lot number does not exist.Received one used.List #am6109, 10" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer; lot #unknown.Received one photo showing the defective product with an arrow indicating where the leak occurred.The complaint of leak can be confirmed on the returned sample.There were residuals observed inside the luer connector of the female luer and the male luer of the manifold.The set was leak tested per product specification and a leak was observed between adaptor fill and manifold.The female adaptor was observed to not be fully inserted into the male luer of the manifold.The probable cause of the leakage observed is due to incomplete insertion between adaptor fill and manifold during the manual assembly at the manufacturing site.The device history report (dhr) for lot 11001834, 6042707 was reviewed and no non conformities were found that would have led to the reported complaint.The device history report (dhr) lot 6403894 could not be conducted due to that lot number not existing.

Event Description

The event involved a 10" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer where it was reported that the 6 manifold was leaking over the last several days.The leak occurred at the connection next to the tubing going to a baby patient.Moreover, the baby had a significant drop in blood pressure due to the changeover of lines.A patient safety report was filed.The customer also reported that there were no issues noted during initial priming/set-up of the device.The infusion was going over 12 hours since the lines were hung.The customer reported that the patient was okay while connected (and slowly leaking) until the lines were disconnected to prime new tubing.The blood pressure dropped significantly, requiring max dosages of norepi drip and dopamine drip.Normal saline bolus was also given, maxing out the doses, close to coding the patient.The patient¿s status prior to the event was ¿unstablely stable¿ then unstable due to replacing the line.The line change over took about 1 minute.The blood pressure before event maps 30-35, after the event, it maps 12-18 when it should be 30-35.The clinical details surrounding the event were sepsis, hypotension and prematurity.The medications involved were parenteral nutrition (pn), dopamine drip, fentanyl drip and norepinephrine drip.The fluid was noted to be slowly dripping from connection.It was also noted that the end lock was moving freely in a circle, in the d2 part of the product, which usually is stationary.There was patient involvement and patient harm reported.

• Brand Name: 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING
• 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: 16846169
• MDR Text Key: 314326458
• Report Number: 9617594-2023-00167
• Device Sequence Number: 1
• Product Code: FMG
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AM6109
• Device Catalogue Number: AM6109
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: DOPAMINE DRIP, MFR UNK; FENTANYL DRIP, MFR UNK; NOREPINEPHRINE DRIP, MFR UNK; NORMAL SALINE, MFR UNK; PARENTERAL NUTRITION (PN), MFR UNK
• Patient Outcome(s): Life Threatening; Required Intervention