MAUDE Adverse Event Report: ACEMEDICAL LMA; ELASTOMERIC PUMP

Model Number MC0050L

Device Problems Failure to Infuse (2340); Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 02/03/2015

Event Type  Injury  

Event Description

Pt first called (monday night, (b)(6)) the om call provider for pump not dispensing.Reporting md called him (b)(6) at 800 am.Pt was in incredible pain, and after discussion pump did sound full.Trouble shooting included having the pt check to see if the disk was dispensing by very carefully and without touching either end having him disconnect and re-connect.Pump was found to be dispensing.After pt reports he kept checking the pump throughout the day and before he went to bed at 8:00pm.The pump was still at 250 ml, and the pt was in quite a bit of pain all day as well.So based on the pt's vigilance the pump seems to be pretty full at 250 ml for 34 hours since placement.Pt reports making up at midnight with zero pain in his foot and ankle, a metallic taste in his mouth.Pt checked the pump and found it too be at 100 ml.Pt looks to have gotten a bolus dose over 4 hours.

• Brand Name: LMA
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): ACEMEDICAL
• MDR Report Key: 4546568
• MDR Text Key: 16994151
• Report Number: MW5040904
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/19/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MC0050L
• Device Lot Number: A140910-PFCD6000US-1
• Other Device ID Number: 05060112312212
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 112