MAUDE Adverse Event Report: HALYARD - IRVINE PUMP MODEL: 400 DUAL; ON-Q: PUMP 400ML

Model Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problems Tinnitus (2103); Blurred Vision (2137); Toxicity (2333); Confusion/ Disorientation (2553)

Event Date 03/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # unknown.Method: the actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

Fill volume: unknown, flow rate: 4ml/hr, procedure: lap band removal and double hernia repair.A report was received by the nurse hotline stating the patient was at home and started experiencing blurred vision, confusion, drowsiness, metal taste in mouth and tinnitus.The patient removed the pump and the blurred vision, confusion, drowsiness, and the metal taste in mouth stopped.The patient continued to experience tinnitus after the pump was removed.The patient reported that after the pump was removed the device was not empty and had a small amount of medication in it that was discarded with the pump and was not retrievable.Additional information received on 25-mar-2016 stated that the patients only complaint was a report of minor pain.No additional information was provided in regards to the patient's status.

• Brand Name: PUMP MODEL: 400 DUAL
• Type of Device: ON-Q: PUMP 400ML
• 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, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5597506
• MDR Text Key: 43317451
• Report Number: 2026095-2016-06001
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2016

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: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/22/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 159