MAUDE Adverse Event Report: I-FLOW, LLC HOME PUMP C-SERIES: 270ML, 5ML/HR; ELASTOMERIC PUMP

Model Number C270050

Device Problem Infusion or Flow Problem (2964)

Patient Problems Fatigue (1849); Neuropathy (1983)

Event Date 09/27/2014

Event Type  Injury  

Manufacturer Narrative

Method· the devices were reported to be unavailable for return and analysis.A device history record (dhr) review was conducted for the reported lot number.Results: as a device was not available for an evaluation, no methods were performed, therefore results cannot be obtained.The dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot the lot met the process specifications, including the quality control acceptance criteria prior to release.A review of the use conditions and the instruction for use (ifu) was performed and according to the flow table on the ifu 14-60-591-0-03.This pump model filled to 244ml's will complete infusion in about 48 hours with a tolerance of +/-15%.Therefore the approximate infusion time for 244ml's will be between 40 8 hours and 55.2 hours.The ifu also stated "filling the pump less than labeled (nominal) fill volume results in faster flow rate.Conclusions: the device was not returned to i-flow for an evaluation, therefore we are unable to determine a cause for the reported event.Should additional information be received, a follow-up report will be submitted.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

Fill volume: 230ml.Flow rate: 5ml/hr.Procedure: chemotherapy cathplace· central line.Report 1 of 3· please reference: 2026095-2014-00222/(b)(4) (b) and, 2026095-2014-00223/(b)(4) (c).Incident #1, patient #1: it was reported by a pharmacy that there were three incidents of fast flow that occurred in separate patients.All three pumps were of the same model and lot number, they were filled ,nth 5-fu and saline to 230ml's.The patients received the pumps at the infusion center and then went home with them.The parents called to report that the pumps had finished earlier than expected all patients used the pumps via central lines.Further information was received regarding the first incident.The patient's pump was filled on september 24,2 014, the pump was started on (b)(6) 2014 at 7:00pm.The pump was reported to have completed infusion on (b)(6) 2014 at 4:00am.The patient reported that the pump was visually empty at the end of the infusion.The patient experienced fatigue and peripheral neuropathy after infusion.

• Brand Name: HOME PUMP C-SERIES: 270ML, 5ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4275226
• MDR Text Key: 147088471
• Report Number: 2026095-2014-00215
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/09/2014

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: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: C270050
• Device Catalogue Number: 101356802
• Device Lot Number: 0201325987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 75