MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC THREE GANG LARGE BORE STOPCOCK MANIFOLD; STOPCOCK, I.V. SET

Catalog Number 2C6218

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems Cardiac Arrest (1762); Exsanguination (1841)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a patient experienced significant blood loss leading to a near fatal arrest after a separation/ disconnection of a three gang large bore stopcock manifold occurred while in use.The device became separated/ disconnected at "the points where the stopcocks are fused".The device was in use with an unreported medication.The cause of the separation was not reported.It was reported after the separation occurred, the patient subsequently exsanguinated and ¿arrested¿ (no further details).Treatment and interventions for the events were not reported.At the time of this report the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THREE GANG LARGE BORE STOPCOCK MANIFOLD
• 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; parque industrial itabo, piisa; haina, san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7970790
• MDR Text Key: 123878169
• Report Number: 1416980-2018-06581
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00085412003863
• UDI-Public: (01)00085412003863
• 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,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Catalogue Number: 2C6218
• Device Lot Number: DR18E02047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• 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
• Patient Outcome(s): Other