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

Model Number 01C-42640-06

Device Problem Disconnection (1171)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to the manufacturer for investigation.It has not been received.Investigation is not complete.

Event Description

The event involved a customer allegation regarding a transpac iv monitoring kit stating that approximately one hour into infusion the pressure line was disconnected/broken from the safeset blood withdrawing port.The device was replaced with no further problems encountered.There was patient involvement, however, there was no adverse event and no delay in critical therapy.The device was used with a phillips monitor for blood pressure monitoring and heparinized saline medication.

Manufacturer Narrative

Icu medical testing facility received one (1) used partial set 01c-42640-06 transpac® iv monitoring kit with safeset; reported lot# 3514084.As received, a tubing separation was observed between the 27" arterial pressure tubing and the safeset port.The probable cause of the tubing separation was insufficient solvent applied to the bond.The reported complaint of tubing breakage or separation was confirmed.A review of lot# 3514084 showed (b)(4) units were manufactured, tested, and inspected and released october 2017.There were no non-conformities noted.

• Brand Name: TRANSPAC® IV MONITORING KIT WITH SAFESET¿
• Type of Device: TRANSPAC® IV MONITORING KIT WITH SAFESET¿
• 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
• Manufacturer (Section G): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• Manufacturer Contact: patricia sharpe-gregg, bsn, rn ; 600 n. field drive, 2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 7873433
• MDR Text Key: 120255907
• Report Number: 9617594-2017-00050
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 01C-42640-06
• Device Catalogue Number: 01C-42640-06
• Device Lot Number: 3514084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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: HEPARINIZED SALINE; PHILLIPS MONITOR