MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC IT TRIFURCATED MTG. KIT

Model Number 011-46108-02

Device Problems Loss of or Failure to Bond (1068); Break (1069)

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

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

Initial investigation a review of the mfg.Lot build database for the reported lot# 3163015 (mfg.02/2016) showed (b)(4) units were mfg., tested, inspected and released.There were no exception documents generated during the lot build.Device return: one used 01146108-02 partial segment and one packaged 011-46108-02 same lot sample have been returned.Qe investigation is in progress.

Event Description

Int'l.(b)(6) complaint received reporting component separation/leakage with use of one 011-46108-02 it trifurcated transpac w/safeset mtg.Kit.The initial information received reports ".The tubing came away from bonding of transducer on the pa line of the triple kit.Theatre staff tied off the pa line and continued with only the arterial and cvp lines functioning".There were no reported patient injuries/adverse consequences.

Event Description

Int'l.(b)(6) complaint received reporting component separation/leakage with use of one (b)(4) it trifurcated transpac w/safeset mtg.Kit.The initial information received reports".The tubing came away from bonding of transducer on the pa line of the triple kit.Theatre staff tied off the pa line and continued with only the arterial and cvp lines functioning".There were no reported patient injuries/adverse consequences.This is the mfgers.Follow up report to provide the device return investigation results/codes.

• Brand Name: TRANSPAC IT TRIFURCATED MTG. KIT
• Type of Device: TRANSPAC IT TRIFURCATED MTG. KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5998383
• MDR Text Key: 56450532
• Report Number: 2025816-2016-00091
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: 011-46108-02
• Device Catalogue Number: 011-46108-02
• Device Lot Number: 3163015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1