MAUDE Adverse Event Report: I-FLOW, LLC HOMEPUMP C-SERIES 270ML, 10 ML/HR; ELASTOMERIC PUMP

Model Number C270100

Device Problem Infusion or Flow Problem (2964)

Patient Problems Hyperthermia (1909); Reaction (2414)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Fill volume: exact amount unk, between 140ml or 160 ml.Flow rate: 10 ml/hr.{please reference 2026095-2014-00138/14-00589 (a), 2026095-2014-00139/14-00589 (b) and 2026095-2014-00140/14-00589 (c) and 2026095-2014-00141/14-00899 (d) which have already been reported initially on 08/13/2014}.Add'l info was provided regarding pt #2 and two add'l fast flow incidents were reported for this pt.Please reference 2026095-2014-00196/14-00589 (f) which is being reported along with this report.Pt 2, incident 1 of 2: beginning on (b)(6) 2014 for 15 days, infusions have not been running as expected.Two add'l fast flow incidents were reported for pt two.It was waited less than one minute between filling the pump and placing it on the pt.It was reported that the infusion time was within 11 hrs, instead of 12 hrs and this occurred twice.The pump was filled with tazocilline/naci 0.9%.The pt was reported to have experienced hyperthermy on day 1 and day 2 of the treatment and was treated with paracetamol.No further info regarding this pt was reported.The indication of the antibiotic therapy was unk.The pumps have been discarded.

Manufacturer Narrative

Method: the device were reported not to be available as they were discarded, therefore testing methods could not be performed.A review of the device history record (dhr) was conducted for the lot number reported.Results: according to the dhr review, the production lot met all manufacturing and quality specifications.As a device was not available for an eval no methods were performed, therefore, results cannot be obtained.Conclusions: the device was not returned to i-flow for eval, therefore, we are unable to determine an exact cause for the reported event.Based on the reported info, the device was used less than one minute after filling.Product complaint and mdr trend reporting systems.Trend info is used to identify the need for add'l investigations.

• Brand Name: HOMEPUMP C-SERIES 270ML, 10 ML/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: 4172264
• MDR Text Key: 5096150
• Report Number: 2026095-2014-00195
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/12/2014

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: 02/29/2016
• Device Model Number: C270100
• Device Catalogue Number: 101356900
• Device Lot Number: 201122658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: TAZOCILLINE/NACI 0.9%
• Patient Age: 25 YR