MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IT MONITORING KIT; CUSTOM KIT FOR SWITZERLAND

Model Number 011-0J736-01

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned.It has not been received.The lot number of the device that was in use is unknown.The customer contact identified four possible lot numbers (plots).The possible lot numbers are 3424632, 3076351, 3360746, and 3300368.Expiration dates for the possible lot numbers are: 3424632 - 3/2020, 3076351 - 6/2018, 3360746 - 11/2019, and 3300368 - 7/2019.Device manufacture date for the possible lot numbers are: 3424632 - 4/2017, 3076351 - 6/2015, 3360746 - 11/2016, and 3300368 - 8/2016.

Event Description

The customer reported two events occurred on unspecified dates in 2018.This report is for the first event.The event involved a transpac iv set that disconnected at the junction point with the luer connector.The customer reported this lead to blood loss for the patient that had no repercussion on the patient's health condition.There was no reported delay of critical therapy and no medical interventions required.

Manufacturer Narrative

No product was received for investigation, but two photos showed arterial tubing separation.The cause of the separation cannot be determined without the product being returned for investigation.A dhr (device history record) review was completed on the following suspect lot numbers: 3424632, 3076351, 3360746, 3300368.No non-conformities were noted for the assembly and relevant subassemblies.This complaint is related to pr (b)(4), which had two (2) samples returned for investigation and that complaint was confirmed due to insufficient solvent for one of the samples.Two other prs are also related (b)(4), which had no product returned.The reported complaint of tubing separation was confirmed.Without the actual sample returned, the cause of the separation cannot be determined.Subsequent to the submission of the initial medwatch report, the device did not return for evaluation.

• Brand Name: TRANSPAC IT MONITORING KIT
• Type of Device: CUSTOM KIT FOR SWITZERLAND
• 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: regina rose ; 600 n. field drive, bldg h2-2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 7277081
• MDR Text Key: 100512384
• Report Number: 9617594-2018-00025
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 011-0J736-01
• Device Catalogue Number: 011-0J736-01
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1