MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 42801-03

Device Problems Unable to Obtain Readings (1516); High Readings (2459)

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

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

Received one used.List #42801-03, transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, un-bonded macrodrip; lot #13409114.10/12/2023 the reported complaint of inaccurate readings was confirmed on the returned sample.No visual anomalies were observed.The transpac was electrically tested, and a wave form was able to be zeroed with the waveform beyond the specifications.Further, a bend and twist test was conducted on the cable and a pivot test was completed on the boot and interruptions were observed on the monitor.The transducer is a vendor purchase part.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

Event Description

The event involved a transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, un-bonded macrodrip where it was reported the product was being used to transduce an arterial line pressure for a patient and was initially providing a reading, then for no apparent reason stopped providing a reading.They troubleshot the line, re-zeroed, checked the catheter, but were unable to produce any values.They then were able to successfully use a different set of tubing to obtain a reading.There was no adverse event, and no one was harmed as a result of the reported event.Investigation was completed, the transpac was electrically tested, and a wave form was able to be zeroed with the waveform beyond the specifications.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18357829
• MDR Text Key: 331203392
• Report Number: 9617594-2023-01179
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709120655
• UDI-Public: (01)00887709120655(17)251101(10)13409114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42801-03
• Device Lot Number: 13409114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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: ARTERIAL LINE CATHETER, UNK MFR