MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IT W/ SAFESET¿ RESERVOIR, RED STRIPE TUBING AND NEEDLESS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46103-93

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received and is pending investigation.

Event Description

The customer reported transpac safeset experienced a leak.It was further described that blood was spraying out of side collection point of flushing when returning blood from retractable aspiration.There was patient involvement but no one was harmed as a result of the event.

Manufacturer Narrative

One used device was received for evaluation.The returned monitoring kit was pressure leak tested and met product specifications.Therefore, the reported complaint of leakage from the side port valve of the safeset kit could not be confirmed.A lot history review was was reviewed and there were no relevant non-conformances found.

• Brand Name: TRANSPAC® IT W/ SAFESET¿ RESERVOIR, RED STRIPE TUBING AND NEEDLESS VALVE
• Type of Device: 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: 9235816
• MDR Text Key: 204575885
• Report Number: 9617594-2019-00361
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619042868
• UDI-Public: (01)00840619042868(17)211001(10)3816966
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 011-46103-93
• Device Lot Number: 3816966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1