MAUDE Adverse Event Report: HALYARD ON-Q PUMP 600ML, 2-14ML/HR SAF (1-7ML/HR DUAL); ELASTOMERIC PUMP

Model Number P600X1-7D

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

Fill volume: 7500ml.A pump pre-filler reported that a pump "made a pop sound and pump is no longer firm.No leaks were detected, discovery was mde during filling process".There was no pt contact.On 01/27/2015, upon receipt and visual analysis of the device, it was discovered that the inner latex membrane and the kraton membrane were ruptured.

Manufacturer Narrative

Method: the device was received for analysis.A visual inspection was performed anda review of the device history record (dhr) is in process.Results: there are no device testing results available as the investigation and eval are currently in progress.However, upon visual inspection of the device, it was discovered that the inner latex membrane and the kraton membrane were ruptured.Conclusions: once the analysis and investigation are completed a follow up report will be submitted.Info from this incident has been included in our product complaint nad mdr trend reporting systems.Trend info is used to identify the need for add'l investigations.

• Brand Name: ON-Q PUMP 600ML, 2-14ML/HR SAF (1-7ML/HR DUAL)
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4511924
• MDR Text Key: 15238408
• Report Number: 2026095-2015-00060
• Device Sequence Number: 1
• Product Code: MEB
• 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: Health Professional,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: P600X1-7D
• Device Catalogue Number: 101367902
• Device Lot Number: 0201338125
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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
• Treatment: DRUG: 0.2% ROPIVACAINE