MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,270X2D,P.ONLY,-,OQ,5; ELASTOMERIC LFR

Model Number P270X4D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

Method: the actual device was not returned.Since the lot number of the device involved in the event was not reported, a review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

Event Description

Fill volume: 125 ml, flow rate: 4 ml/hr, procedure: rib plating, cathplace: unknown, pump start time: (b)(6) 2017 unknown time, pump stop time: (b)(6) 2017 5:36 pm.It was reported that a intensive care unit patient experienced a seizure in the early morning 12-hours after using the elastomeric pump, which followed her rib plating procedure.The pump was placed on (b)(6) 2017, and was not labeled with what medication was in the pump.The pump was pulled on the night of (b)(6) 2017 and was discarded.It was unknown if the patient experienced anymore seizures, and there was no further report on the patient's status.Additional information received on 28-feb-2017 stated that an internal investigation was performed and it was discovered that the seizure was not related to the use of the pump.No additional information was provided.

• Brand Name: SURGPN,270X2D,P.ONLY,-,OQ,5
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, bc 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6407611
• MDR Text Key: 70030008
• Report Number: 2026095-2017-00043
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651136726
• UDI-Public: 30680651136726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2017

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?: No
• Device Operator: Other
• Device Model Number: P270X4D
• Device Catalogue Number: 101367200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ROPIVICAIN 0.2%
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 72