MAUDE Adverse Event Report: I-FLOW RA PCA & SAF 2-14:400 ML, 2-14 ML/HR+5 ML/30 MIN; ELASTOMERIC PUMP

Model Number 4440008

Device Problem Infusion or Flow Problem (2964)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 05/25/2014

Event Type  Death  

Event Description

Fill volume: 400.0 ml.Flow rate: 8.0 ml/hr.Procedure: duodenopancreatectomy.Cathplace: epidural.A report was received from an international dist, originating from a hosp, and described that a (b)(6) year old female pt experienced a fast flow and passed away 24 hours after using the product."the pump was installed in the pt and the flow was programmed for 8ml per hour with ropivacaine 0.2%, after 12 hours all the content of 400ml had been infused.The pump has a pca device that was no unlocked.According to the report, the pt had significant hypotension and there is 24 hours that the pt came to death.The volume that should be infused in 50 hours was infused in 12 hours." additional info received (b)(6) 2014: hosp contact confirmed that the cause of death is not due to the use of the device.The pt was ill and had pancreatic cancer.Autopsy was not performed.{2026095-2014-00086/14-00466}.The hosp confirmed that "the pt has a pancreas tumor and developed sepsis after a duodenopancreatectomy".

Manufacturer Narrative

Method: the suspect device is being returned for investigation and analysis, but at the time of this report has not been received by the mfr.A review of the device history record (dhr) was conducted for the lot number reported.A photographic image was received from the dist of the suspect unit.Results: results will be provided once the evaluation and investigation have been completed.The dhr review concluded that the lot passed all mfg specifications at release.The photographic image received shows that the red tab of the device is in place.Conclusions: at this time i-flow is pending the return of the device for an evaluation and analysis.The investigation is currently ongoing, once completed a follow-up report will be submitted.The directions for use provide a warning regarding the red tab as indicated below: warning: do not pull the red tab upwards as breakage could occur (figure 6c).If red tab is not removed or breaks while removing, continuous delivery will occur.This delivery may be significantly greater than the total flow rate (bolus+basal).Info from this incident will be included in our product complaint and mdr trend reporting sys.Additional investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.

• Brand Name: RA PCA & SAF 2-14:400 ML, 2-14 ML/HR+5 ML/30 MIN
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW; llc; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3918816
• MDR Text Key: 4514162
• Report Number: 2026095-2014-00086
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/03/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 4440008
• Device Catalogue Number: 101353100
• Device Lot Number: 0200912257
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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: DRUG: ROPIVACAINE 0.2%
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Weight: 70