MAUDE Adverse Event Report: ICU MEDICAL, INC. CARDIAC OUTPUT CABLE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	501340401
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
Event or Problem Description
The event involved a cardiac output cable where it was reported that the rubber piece close to the connection to the catheter slips off very easily causing wire exposure.The product was not reprocessed or re-sterilized prior to use.The customer reported they are having trouble with the adhesive on the cables, and have seen the damage when cables are taken out of the packaging and plugging them in.There was patient involvement and unknown harm.
Additional Manufacturer Narrative
Photographs were provided by the customer showing the involved device.The reported complaint of the rubber piece connecting to the catheter slips away was not confirmed from the image provided by the customer.No sample or videos were returned for evaluation.However, an image was provided by the customer showing the involved device.A failure mode was not able to be identified from the image provided by the customer.Without the return of the reported sample, a probable cause could not be determined.A dhr review could not performed since the customer has not provided the lot number for the reported cable.
Additional Manufacturer Narrative
Correction in d4.Only the di is provided as lot/serial is unknown.

• Brand Name: CARDIAC OUTPUT CABLE
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18182897
• Report Number: 1713468-2023-00004
• Device Sequence Number: 7717060
• Product Code: DRS
• UDI-Device Identifier: 00840619040932
• UDI-Public: 00840619040932
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

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: 501340401
• Device Lot Number: UNKNOWN
• 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: 10/28/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 12/22/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/15/2024; 07/11/2024
• 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
• Patient Sex: Unknown