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

Model Number 42587-05

Device Problems Device Inoperable (1663); Defective Device (2588); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2018

Event Type  malfunction  

Event 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
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR, CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7475464
• MDR Text Key: 106995310
• Report Number: 7475464
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619033552
• UDI-Public: (01)00840619033552
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 04/16/2018
• Event Location: Other
• Date Report to Manufacturer: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 104