MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	460990471
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.E1 - additional contact telephone number - (b)(6).
Event or Problem Description
The event involved monitoring kit w/safeset¿ ii, 03 ml flush device & marvelous valve where the customer reported that the device leaked.The nurse set-up pressure tubing and and connected it to patient and noted that blood was backflowing into the set.She then realized there was a leak in the system.She disconnected the set and replaced it with another pressure tubing set which worked without issue.The leak occurred at the flush chamber just above where fluid would enter the chamber.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The following was provided by the customer for investigation: one used list #460990471, monitoring kit w/safeset¿ ii, 03 ml flush device and marvelous valve; lot #14040706.The reported complaint of leak was confirmed on the returned set.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested, a channel leak was observed between the tubing and the safeset reservoir.The white syringe cap of the safeset reservoir was opened and the barrel was removed.When the rest of the set was primed with a red dye to check the area of the leak, a leak was observed between the tubing and the washed safeset seal area.It is unknown how the leak had occurred.The probable cause of the leak is unknown.The device history record and relevant commodity records were reviewed, no discrepancy was identified.
Additional Manufacturer Narrative
Additional information can be found in b5, d10 e1, e3, e4 and g2.
Event or Problem Description
Additional information regarding this complaint was received as follows: a medsun medwatch uf/importer report # (b)(4) was received on 27-nov-2024 that stated "icu medical device a-line pressure tubing set leaked when rn put connected the set to ivf in a pressure bag.Rn set up pressure tubing and connected to patient and noted that blood was backflowing into the set.She then realized there was a leak in the system.She disconnected the set and replaced it with another pressure tubing set which worked without issue.The leak occurred at the flush chamber just above where fluid would enter the chamber." this issue was originally reported by (b)(6), a nurse of (b)(6) hospital.

• Brand Name: MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 20359675
• Report Number: 9617594-2024-01375
• Device Sequence Number: 7208974
• Product Code: DRS
• UDI-Device Identifier: 00840619069087
• UDI-Public: (01)00840619069087(17)270601(10)14040706
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

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: 460990471
• Device Lot Number: 14040706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/28/2024; 11/27/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/07/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: UNSPECIFIED ARTERIAL LINE, MFR UNK; UNSPECIFIED PRESSURE BAG WITH IVF, MFR UNK
• Patient Sex: Unknown