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

Model Number	P270X4D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	02/16/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6407611
• Report Number: 2026095-2017-00043
• Device Sequence Number: 512906
• Product Code: MEB
• UDI-Device Identifier: 30680651136726
• UDI-Public: 30680651136726
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: P270X4D
• Device Catalogue Number: 101367200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/15/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVICAIN 0.2%
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Weight: 72