MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC STOPCOCK; STOPCOCK, I.V. SET

Catalog Number 2C6218

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A three gang stopcock manifold being used to deliver a bolus of levophed leaked and caused the patient to experience hypotension during a heart transplant procedure.The anesthesiologist reported that during the procedure, the patient's blood pressure dropped to an unknown rate.In order to reverse the hypotension, it was noticed that the stopcock was leaking from a crack in the rigid bond between the first (stopcock a) and second stopcock (stopcock b) closest to the female luer.To resolve the issue, the anesthesiologist turned off the controller lever on stopcock b, broke stopcock a off, connected a new stopcock (stopcock c) to stopcock b and reconnected the primary set to stopcock c and administered a bolus of levophed (norepinephrine).This resulted in the patient being hypertensive.The hypertensive episode was resolved (no further detail was provided).It was reported that no further adverse events occurred with the patient.No further information was provided regarding the patient's outcome from the event.No additional information is available.

Manufacturer Narrative

Additional information: device manufacture date, evaluation codes, and additional mfr narrative.Evaluation codes were provided.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5924473
• MDR Text Key: 53803785
• Report Number: 1416980-2016-14786
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CLEARLINK BLOOD RECIPIENT SET; LEVOPHED (NOREPINEPHRINE)
• Patient Outcome(s): Required Intervention