MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET

Catalog Number 2C8931

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017)

Patient Problem Overdose (1988)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A surgical patient experienced an over infusion due to a use error related to the clearlink manifold.The cause of the event was further described by the reporter as the nurse went to withdraw blood from the y-site closest to the patient; however, a bolus of rocuronium was infused to the patient from the syringe attached at the port due to the nurse not closing the slide clamp above the y-site prior to trying to withdraw the blood.This caused the syringe to be activated upstream, giving the patient the added dose (amount not specified) of rocuronium.The patient required intubation ¿longer post-operatively¿ and was mechanically ventilated until ¿the medication wore off¿.At the time of this report, the patient was in stable condition and has recovered from the event.No additional information is available.

Manufacturer Narrative

(b)(4) additional information: device evaluated by mfr?.Evaluation codes added.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition; however, it was observed that the bottom section of tubing below the stopcock had been removed by the customer and not returned.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5706205
• MDR Text Key: 46794290
• Report Number: 1416980-2016-10413
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 2C8931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 63