MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT; TRANSPAC® IV MONITORING KIT

Model Number	42648-06
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) used transpac iv monitoring kit was received and evaluated.A tubing separation was observed in the 3" arterial pressure tubing and the safeset port.The cause of the separation was insufficient solvent bond on the tubing.
Event or Problem Description
The customer reported the arterial line became disconnected at a junction point during patient use.It was reported that the monitor was able to sense an arterial line disconnection.There was a small amount of blood loss reported but no report of adverse event or delay in critical therapy.
Additional Manufacturer Narrative
Subsequent to the initial medwatch, a user facility medwatch was received with additional information.
Event or Problem Description
The event occurred during blood pressure monitoring.

• Brand Name: TRANSPAC® IV MONITORING KIT
• Common Device Name: TRANSPAC® IV MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7307640
• Report Number: 9617594-2018-00029
• Device Sequence Number: 19051837
• Product Code: DRS
• UDI-Device Identifier: 00840619045012
• UDI-Public: 00840619045012
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: Nurse
• Device Model Number: 42648-06
• Device Catalogue Number: 42648-06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 104