MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR, CATHETER, CONTINUOUS FLUSH

Model Number	42587-05
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The ir team was planning to use this monitoring device that measures blood pressure within the fistula during a procedure.However, the team attempted to assemble the product they realized one of the pieces was bonded together.The team obtained another kit, however, upon opening it, they found that the product was again bonded.The team then pulled all of the product in stock (7 products) and found that 6 of those products had the same lot number as the product that we discarded and 1 had a different lot number.The team opened the product that had its own lot number and that product was fine and worked as it should have.Upon later inspection of the other remaining 6 with the same "bad" lot numbers were bonded.This product has since been taken out of circulation.The lot number for the defective kits is 3598346.The kit the team ended up using in this procedure that was not bonded is from lot 3338172.

• Brand Name: TRANSPAC
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR, CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7475464
• Report Number: 7475464
• Device Sequence Number: 2157021
• Product Code: DRS
• UDI-Device Identifier: 00840619033552
• UDI-Public: (01)00840619033552
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2018
• Report Date (Section F): 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 01/01/2021
• Device Model Number: 42587-05
• Device Catalogue Number: 42587-05
• Device Lot Number: 3598346
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 04/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 104
• Date Report Sent to FDA: 04/16/2018