MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46110-29

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Event Description

The event involved a transpac® iv monitoring kit w/03 ml squeeze flush device, safeset¿ reservoir, 84" red stripe arterial pressure tubing and 2 needleless valves which was reported to have leaked isotonic solution for arterial catheter during patient use.The customer reported that a line where one of the connections, normally crimped, was leaking.The customer reported a delay in therapy, about 20 min (two circuits to re-prime and reinstall).The patient¿s condition was said to be unmodified.The device was removed and reinstalled under strict aseptic conditions twice.There was no physical defect noted before use.The leak was cleaned-up as per facility protocol.There was patient involvement, however, no harm was reported as a consequence of this event.

Manufacturer Narrative

One used device was returned for evaluation on 8/29/23.No visual anomalies were observed on the returned set.The returned set was primed and pressure leak tested; no leaks were observed.The product performed per the specifications.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84
• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17190665
• MDR Text Key: 317758677
• Report Number: 9617594-2023-00263
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619068684
• UDI-Public: (01)00840619068684(17)250601(10)6032802
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46110-29
• Device Lot Number: 6032802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ISOTONIC SOLUTION, MFR UNK