MAUDE Adverse Event Report: I-FLOW PUMP; ELASTOMERIC PUMP

Model Number UNK - *ANP*

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

Patient Problems Tinnitus (2103); Reaction (2414); Shaking/Tremors (2515)

Event Date 07/25/2014

Event Type  Injury  

Event Description

Fill volume: unk - *anp*.Flow rate: unk - *anp*.Procedure: bilateral mastectomy with reconstruction surgery.Cathplace: bilateral paravertebral.It was reported that a pt called a nurse to report that she was experiencing a metallic taste in her mouth.Buzzing/vibrating in her ears and shaking.The incident occurred on (b)(6) 2014 post-op day 3.The pt had dual paravertebral catheters placed.The pt reported no issues the day before ((b)(6) 2014) when she spoke with the nurse.The pt's husband clamped the line and removed both catheters.The nurse contacted the pt at 12:30 on (b)(6) 2014 and the symptoms had reportedly resolved.The pt also reported the pump was the size of lemon upon removal.*anp: asked not provided*.

Manufacturer Narrative

Method: the device was reported to be returning for an analysis, at this time we are pending receipt.As the reporter did not have any info regarding the suspect device we are unable to do a device history record (dhr) review at this time.Results: results will be provided once the device evaluation and investigation have been completed.Conclusions: additional info has been requested from the reporter, but is not yet available at this time.Once the device is received and the investigation and device analysis are completed, a follow-up report will be submitted.Info from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.

• Brand Name: PUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4092024
• MDR Text Key: 4747156
• Report Number: 2026095-2014-00146
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2014

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: Lay User/Patient
• Device Model Number: UNK - *ANP*
• Device Catalogue Number: UNK - *ANP*
• Device Lot Number: UNK - *ANP*
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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: UNK - *ANP*
• Patient Outcome(s): Other