MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK; STOPCOCK, I.V. SET

Catalog Number	B55005
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 14" (36 cm) ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext where it was reported that blood backed up into the manifold and started to leak from the green port.Two medications (dobutamine and milrinone) were infusing into the red and blue ports at a total of 5ml/hr.The maintenance line was infusing at 20ml/hr.Despite this 25ml/hr infusion, blood backed up from the pa line vip port into the manifold and started to leak from the green port.The green and yellow ports were not being used nor were they capped.There was patient involvement, however, no report of patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: d4: only di provided as lot number is unknown.E1 initial reporter phone number: ext.(b)(6).
Event or Problem Description
Additional information received from the customer on 22-jul-2024.It was stated that there was a delay in the critical therapy when the problem was noted.There were concerns that the infusion of the inotropes was not occurring, and the patient may have been underdosing.The caregiver capped the ports and when safe to do so, changed the patient¿s manifold to another one to prevent further concerns.
Additional Manufacturer Narrative
Three photos were provided by the customer showing the manifold and the sheets from the patient.The sheets had blood on them.The area of leakage could not be observed from the photos provided.Received one used b55005 for inspection.No defects or anomalies noted.No mating devices were returned for inspection.The set was leak tested per product specifications.There was no leakage anywhere or through the side ports.The reported complaint can be confirmed from the photo provided.The probable cause is unknown.The complaint was unable to be replicated.A lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19760942
• Report Number: 9617594-2024-00901
• Device Sequence Number: 8514034
• Product Code: FMG
• UDI-Device Identifier: 00887709010079
• UDI-Public: 00887709010079
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: B55005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DOBUTAMINE, UNK MFR; MILRINONE, UNK MFR; UNSPECIFIED TUBING
• Patient Sex: Unknown