MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" EXT SET, 3 GANG 1O2 MANIFOLD W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET

Model Number B55013

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation, but is yet to be received.

Event Description

The event was noted on the nightshift and involved a 12¿ extension set, 3 gang 1o2® manifold w/baseplate, rotating luer where a small crack was noted in the manifold causing lifesaving medication to slowly leak, reporting the leakage was subtle so accumulation was not noted.Leaking was noted at the bridge and a wet spot on the linen was noted where the bridge sat.Vasopressors (epinephrine, norepinephrine), narcotics (fentanyl, dilaudid), iv sedation (propofol) or maintenance iv¿s (d5/.9 or ns) were infusing through the 3 ports.The set up was continuous iv tubing with a minibore extension set, connected to the bridge of the device, which was in use within hours.The event was discovered when the patient became more conscious, fighting the ventilator or a blood pressure drop was noted due to leakage of medications.The patient experienced a drop in blood pressure requiring an intervention of a continuous infusion with the provided drugs used during the event to increase the patient¿s blood pressure and improve patient condition to avoid extubation and make the agitated patient more settled as the patient became restless and tried to pull out their breathing tube.It was reported that the patient was stable before the event, became unstable and a continuous infusion with the provided drugs used during the event to improve the patient condition, and then stabilized.

Manufacturer Narrative

One used list#: b55013, 12" ext set, 3 gang 1o2¿ manifold w/baseplate, rotating luer (lot#: 5039847) and two microclave connectors (list#: unknown, lot#: unknown) were received and visually inspected.As received, drug residuals were present within the extension set.Two axial cracks were identified on the proximal female luer of the b55013 set.This type of cracking is consistent with environmental stress.No mating devices were returned connected to the damaged luer.The two microclaves were manually disconnected from the manifold ports and examined.No additional damage or anomalies were observed.The reported complaint of a crack resulting in leakage can be confirmed.The probable cause of the cracks observed is due to environmental stress applied to the luer during use.A device history review of lot#: 5039847 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.D9: the device was received on 3/22/2021.

Event Description

Information was received stating that the nurses at the facility only manually tighten the device and use chlorhexidine gluconate (chg) wipes to wipe the device.

• Brand Name: 12" EXT SET, 3 GANG 1O2 MANIFOLD W/BASEPLATE, ROTATING LUER
• 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
• MDR Report Key: 11467372
• MDR Text Key: 239435780
• Report Number: 9617594-2021-00078
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709010116
• UDI-Public: (01)00887709010116(17)251001(10)5039847
• 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,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B55013
• Device Catalogue Number: B55013
• Device Lot Number: 5039847
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.9 NS, MFR UNK.; CONTINUOUS TUBING SET, BAXTER, PRODUCT CODE 2C8519.; D5 NS, MFR UNK.; DILAUDID, MFR UNK.; EPINEPHRINE (UNK MFR).; FENTANYL, MFR UNK.; MINIBORE EXTENSION SET, 10-1013XL, MFR UNK.; NOREPINEPHRINE, MFR UNK.; PROPOFOL, MFR UNK.
• Patient Outcome(s): Life Threatening