MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT W/SAFESET RESERVOIR AND BLOOD SAMPLING PORT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426480406
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) used partial transpac iv monitoring kit w/ safeset reservoir and blood sampling port was received for testing and investigation.The reported complaint of a tubing disconnection was confirmed.As received, the used partial monitoring kit was missing the 3" length or arterial tubing, which was separated from the rest of the set.It appears that there was insufficient solvent in the safeset port tubing pocket.The cause of the tubing separation cannot be determined without the tubing returned for examination.The dhr lot # 3751448 and relevant commodities were reviewed and there were no non-conformances found that would have contributed to the reported complaint.
Event or Problem Description
The event involved a transpac iv monitoring kit w/safeset reservoir and blood sampling port where the tubing adjacent to the blood sampling port pulled loose.The product was replaced with no further problems encountered and is available for investigation.There was patient involvement, no human harmed or adverse event and no delay in critical therapy.

• Brand Name: TRANSPAC IV MONITORING KIT W/SAFESET RESERVOIR AND BLOOD SAMPLING PORT
• 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
• MDR Report Key: 8139112
• Report Number: 9617594-2018-00217
• Device Sequence Number: 13729791
• Product Code: DRS
• UDI-Device Identifier: 00840619045012
• UDI-Public: (01)00840619045012(17)210801(10)3751448
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 426480406
• Device Lot Number: 3751448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1