MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42801-28
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Distributor contact details: (b)(6).
Event or Problem Description
The reported complaint occurred on an unspecified date and involved a transpac¿ it monitoring kit, 84" safeset reservoir, 2 blood sampling port, 3ml flush device, un-bonded macrodrip.It was reported that the a line transducer came off of the blue clip.An attempt to place it back on was unsuccessful.The a line wires then detached from the transducer.The entire a- line set had to be replaced.There were no injuries or adverse event/harm associated with the reported event.
Additional Manufacturer Narrative
The following was received for complaint investigation: -one new list #42801-28, transpac¿ it monitoring kit, 84" safeset reservoir, 2 blood sampling port, 3ml flush device, un-bonded macrodrip; lot #13532559.No visual anomalies were observed on the returned set.The transducer was electrically tested.The transducer was connected to a monitor and a 100 mmhg dead weight tester.The transducer was zeroed and when opened to the dead weight tester, the sample showed a value of 100 mmhg, which is within the released product specification of 100 mmhg +/- 1 mmhg.Further, a bend and twist test was conducted on the cable and a pivot test was completed on the boot; no interruptions were observed on the monitor.Without the return of the actual used sample in question, the complaint could not be confirmed.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Updated information can be found in g1.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F
• 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: 17603104
• Report Number: 9617594-2023-00587
• Device Sequence Number: 17713107
• Product Code: DRS
• UDI-Device Identifier: 00887709120778
• UDI-Public: (01)00887709120778(17)260101(10)13532559
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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: 01/01/2026
• Device Catalogue Number: 42801-28
• Device Lot Number: 13532559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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