MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42645-06
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The device involved is a transpac iv monitoring kit.The customer stated that upon attempting to pull blood back in the safe set arterial line tubing from the arterial line placed in the right radial artery, the tubing became disconnected from the stop cock resulting in a small amount of bleeding back from the patient due to the open ended arterial line.Upon attempting to reconnect the tubing and return the waste blood from the safe set to the patient; the line again became disconnected at the same point and again blood sprayed from the line.The line was immediately clamped off and the actual blood loss was minimal (approximately 3 ml at most).The entire set was then changed out.The line was easily flushed and had immediate brisk blood return.There was no change in circulation distally to the line and transducing continued without incident.The patient did not experience pain or discomfort.This was a new set up that had been hooked up to the patient at 2200.No leaks or defects were observed when priming the line.There was patient involvement, however no report of patient harm.
Additional Manufacturer Narrative
The device has been received.Pending investigation.
Additional Manufacturer Narrative
Received one used.List #426450406, transpac® iv monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 60" tubing, disposable transducer, 3 ml intraflo® flush, macrodrip (pole mount); lot #5607507.The reported complaint of disconnection was confirmed on the returned set.An image was provided by the customer showing the set.During visual inspection, a crack was observed on the female luer.Crazing was observed around the crack.A safeset port was found separated from the 3" pressure tubing.The 3" pressure tubing was not returned for evaluation.Without the return of the separated pressure tubing, a probable cause could not be determined.When primed and pressure leak tested, a leak was observed from the crack of the female luer.The probable cause of the crack on the female luer had occurred due to environmental stress cracking during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14142530
• Report Number: 9617594-2022-00082
• Device Sequence Number: 15025685
• Product Code: DRS
• UDI-Device Identifier: 00840619064464
• UDI-Public: (01)00840619064464(17)240901(10)5607507
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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 Expiration Date: 09/01/2024
• Device Model Number: 42645-06
• Device Catalogue Number: 426450406
• Device Lot Number: 5607507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Patient Sex: Male