MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD SAMRTEZ PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number SE0200-100

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2019

Event Type  malfunction  

Event Description

Patient reports entire batch of smartez pumps {18 doses total} [se0200-100, lot: unknown] filled with clindamycin 900 mg in 0.9% sodium chloride 100 ml required excess work to allow the device to infuse.She states, "she has to beat the smartez pumps on the table and squeeze them "like a stress ball" to allow them to infuse." patient also noted it required 90 minutes for devices to infuse instead of infusing over 30 mins every 8 hours (as instructed).

• Brand Name: SAMRTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD
• MDR Report Key: 8253010
• MDR Text Key: 133482118
• Report Number: MW5083131
• Device Sequence Number: 4
• Product Code: MEB
• Combination Product (y/n): N
• 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: 01/11/2019
• 18 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SE0200-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1