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

Catalog Number 886-42584-05

Device Problems Unable to Obtain Readings (1516); Material Separation (1562)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

One used.List #886-42584-05, transpac¿ iv monitoring kit, disposable transducer, 3ml squeeze flush device, macrodrip.The reported complaint of no waveform was not confirmed on the returned set.An image was provided by the customer showing the involved product.During visual inspection, the 12.5" pressure tubing was found separated from the female luer.The tubing pocket was found tacky.The separation of the bond was due to the pressure tubing being tacky.The probable cause of the pressure tubing being tacky is due to the uv adhesive on the tubing not being fully cured during assembly process at ensenada.The transpac was electrically tested and a wave form was able to be zeroed with the waveform visible on the monitor on the returned set.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

Event Description

The event involved a transpac iv monitoring kit, where it was reported that during infusion there was no waveform.The device was returned for investigation and it noted that the 12.5" pressure tubing was found separated from the female leur.There was patient involvement in the original complaint, however no report of patient harm.

• Brand Name: TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE,
• 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: 15301268
• MDR Text Key: 305494916
• Report Number: 9617594-2022-00249
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 886-42584-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNSPECIFIED NORMAL SALINE, UNK MFR