MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP ECLIPSE; ELASTOMERIC PUMP

Model Number ASKU

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problems Sprain (2083); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: it was reported that a range of pumps are filled at the facility.The models are se102000, se101000, e402000, e252500 and se050500.There are no samples available from the same lots used when the individuals experienced their reported symptoms; however, unused sample returns are anticipated.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 testing methods were performed.However, an investigation into this reported incident is still currently in progress.Per the elastomeric pump filling technique technical bulletin (mk-00010), "at times there is high pressure inside the elastomeric bladder that creates resistance when filling the pump.However, with enough force applied, the pressure will be overcome and the pump can continue to be filled.Please note that asymmetrical filling of the pump may also cause resistance during filling once one side has completely filled and the other begins to expand.Per the instructions for use (ifu) for eclipse homepumps (14-60-593-0-03) "the homepump eclipse* pump can be filled with a syringe or similar device.Remove all air from the filling device and attach filled syringe to fill port.Invert pump as shown.Firmly grasp the syringe with both hands and push down on the plunger continuously until the volume is dispensed.Do not handle the pump while filling, as the syringe tip may break.Repeat as necessary." the elastomeric pump filling technique technical bulletin also specifies, "the elastomeric pump should be filled with a 60cc syringe or similar device." "after attaching syringe to the fill port, invert pump as shown below.Firmly grasp the syringe with both hands and push down on the plunger continuously until the volume is dispensed.Resistance may be felt.Repeat as necessary in order to fill the pump completely." conclusions: although, device testing results are not available at this time, the reported incident is still under investigation.Once the investigation is completed a follow-up report will be submitted.The reporter indicated that they fill the pump as per the instructions for use posted on the www.Iflo.Com website.The ifu on the website also specifies the following: the homepump eclipse* pump is designed for patients to use at home.Please see below for important patient information for home use: for 24-hour product support, call (b)(4) (english only).Visit www.Iflo.Com or contact your sales representative for the latest product information and technical bulletins, including but not limited to: drug stability data.Patient information brochures." thus, the technical bulletin on the elastomeric pump filling technique (mk-00010) is readily available on the website.This is the first complaint received related to the reported incident.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.

Event Description

Please reference: 2026095-2015-00222/(b)(6) and 2026095-2015-00242/(b)(6).Case #3 of 3: it was reported by a compounding pharmacy in (b)(6) that they are currently processing a claim of repetitive strain injury due to the filling of pumps.It was reported that "a range of pumps are used, the highest being the 100ml pump.At this time samples of the devices have been requested; however, not received at this time.Additional information has been requested regarding the incident; however, is not available at this time.Additional information was received on 09/08/2015.There are three individuals currently being treated for "various issues and are undergoing various treatments including rest and physio; they are responding to treatment.All of the individuals are female ranging in age from mid-20's to 40; they are all of average height and weight.

Manufacturer Narrative

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.Information from this incident has been included in our product complaint reporting systems for monitoring, tracking and trending purposes.

• Brand Name: HOMEPUMP ECLIPSE
• 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.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5136025
• MDR Text Key: 27844283
• Report Number: 2026095-2015-00243
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: PK052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 09/08/2015

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: Other Health Care 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: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• 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
• Patient Outcome(s): Other