MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿IT MONITORING KIT, 84" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42800-05
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
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
The event occurred on an unspecified date and involved a transducer, 84 inch (213 cm), 3 ml/hr, macrodrip where it was reported there was an instance where the blood pressure (bp) trace reading was either absent or inconsistent.The patient and the invasive bp monitoring circuit, including the arterial line were checked and normal bp reading was confirmed by non-invasive means.The problem of absent or inconsistent bp trace was resolved by changing the transducer.The transducer was in use and attached to an arterial cannula.The system was flushed through with saline and attached to a pressurized bag of saline as per standard procedure.No other medication was delivered through this system.The device is a single pressure monitoring kit used to measure invasive blood pressure through an arterial line, there is no infusion and no administration of medication/chemo involved.It is used for monitoring purposes.The patient was undergoing surgery under general anesthesia, and so various other drugs were delivered via the intravenous route.No chemotherapy was involved.In theatre, the products are usually kept within the theatre stores or in the anesthetic room.The number of transducers involved is one transducer that gave inconsistent bp tracing and also detached from its back panel (consistent bp trace restored by replacing the transducer).There was patient involvement, however, no harm reported.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.D4: only di provided as lot number is unknown.E1 initial reporter phone number: (b)(6).
Additional Manufacturer Narrative
The reported complaint of clue housing separation was confirmed.Images were provided showing the area of the defect.During visual inspection, the blue housing around the transducer was found separated, exposing the wires of the transpac and the white wire was found separated from the transducer.No plastic deformations or visual anomalies were observed on the returned sample.A probable cause of the separation cannot be determined at this time.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿IT MONITORING KIT, 84" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP
• 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: 19927676
• Report Number: 9617594-2024-01079
• Device Sequence Number: 2797753
• Product Code: DRS
• UDI-Device Identifier: 00887709097605
• UDI-Public: 00887709097605
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 42800-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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, UNK MFR; SALINE, UNK MFR; UNSPECIFIED ANESTHESIA, UNK MFR
• Patient Sex: Unknown