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
Medical Device Problem Codes	Unable to Obtain Readings (1516); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9617594-2023-01179
• Device Sequence Number: 6923935
• Product Code: DRS
• UDI-Device Identifier: 00887709120655
• UDI-Public: (01)00887709120655(17)251101(10)13409114
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTERIAL LINE CATHETER, UNK MFR
• Patient Sex: Unknown