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
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, but is yet to be received.
Event or Problem Description
The event 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 for a maximum of 3 days.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.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review of the lot was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 12" EXT SET, 3 GANG 1O2 MANIFOLD W/BASEPLATE, ROTATING LUER
• Common Device Name: 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: 11467385
• Report Number: 9617594-2021-00083
• Device Sequence Number: 4041516
• Product Code: FMG
• UDI-Device Identifier: 00887709010116
• UDI-Public: (01)00887709010116(17)251001(10)5039847
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Model Number: B55013
• Device Catalogue Number: B55013
• Device Lot Number: 5039847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Life Threatening