MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSDUCER, 60 INCH (152 CM), 3 ML/HR, MICRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	011-0P230-01
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An event involving a transducer, 60 inch (152 cm), 3 ml/hr, microdrip experienced inaccurate readings.The following issue was reported by the customer: ¿ an arterial catheter was placed using the kit for measuring the pressure.It was observed that it indicated 45 systole ( which does not match the patient's clinical condition ).It was afterwards observed that it could not be possible to zero the calibration.The catheter worked normally during sampling.Actions taken: a blood pressure measurement with cuff showed a difference of 4 points in the pressure.The team performed a module and cable change, which was ineffective.Finally, the team changed completely the measurement kit, after the change the kit was functional.There were no serious consequences for the patient, however, the patient appeared hypotensive when she was actually normotensive, resulting in a loss of time.".
Additional Manufacturer Narrative
B3 the date of event is unknown.1 jul 2024 has been used as a place holder.D4, g4: model number is not sold in the us but similar device is sold under model xxx.This product was used for the di and 501k.
Additional Manufacturer Narrative
G3 - date received by mfg: this aware date should be corrected to 11 jul 2024.The statement regarding the similar device was missing the similar device material number.D4, g4: model number is not sold in the us but similar device is sold under model 42584-05.This product was used for the di and 501k.
Additional Manufacturer Narrative
The complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.Lot history review was performed and no non conformities were found that would led to the reported complaint.

• Brand Name: TRANSDUCER, 60 INCH (152 CM), 3 ML/HR, MICRODRIP
• 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: 19977735
• Report Number: 9617594-2024-01130
• Device Sequence Number: 8585798
• Product Code: DRS
• UDI-Device Identifier: 00840619027414
• UDI-Public: 00840619027414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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 Catalogue Number: 011-0P230-01
• Device Lot Number: 13835263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 09/03/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/15/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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
• Patient Sex: Unknown