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

Model Number ASKU

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

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Type  Injury  

Event Description

Please reference: 2026095-2015-00180/15-00555(b).Fill volume: asku.Flow rate: asku.Procedure: abdominoplasty.Cathplace: abdominal region.Incident #1 of 2: it was reported that an incident occurred with the use of a pump where the patient lost circulation in the area of the abdomen.The incident occurred approximately 3 weeks ago.The patient was sent for hyperbaric treatment and is reportedly doing ok.The patient did not have signs of infection, hematoma or seroma.The skin was saved.The surgeon supplied the pump from another facility.The device is not available for return.Additional information was requested, however is not available at this time.

Manufacturer Narrative

Vascular system (circulation), impaired.No known device problem.Method - actual device not evaluated.Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Although the exact model pump and catheter was unknown, the instructions for use (ifu) for on-q catheters and introducers ((b)(4)) and an on-q pump with fixed flow rate ((b)(4)) specify the following: "avoid placing the catheter in the distal end of extremities (such as fingers, toes, nose, ears, penis, etc.) where fluid may build up as this may lead to ischemic injury or necrosis." "avoid tight wrappings which can limit blood supply or fluid diffusion." "due to risk of ischemic injury, vasoconstrictors such as epinephrine are not recommended for continuous infusions for the following routes of administration: intraoperative site, perineural and percutaneous (excluding epidural).Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.Based on the limited information, it cannot be determined if user/facility conditions may have caused or contributed to the reported incident.Therefore, the assignable cause could not be determined.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q PUMP 400ML DUAL
• Type of Device: ELASTOMERIC PUMP
• 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. 2211 6; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4880535
• MDR Text Key: 6258870
• Report Number: 2026095-2015-00179
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2015

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: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/30/2015
• 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
• Treatment: ON-Q SILVER SOAKER CATHETERS; MARCAINE 0.25%
• Patient Outcome(s): Required Intervention