MAUDE Adverse Event Report: Q CORE MEDICAL LTD. SAPPHIREPLUS INFUSION PUMP

Catalog Number 15038-000-0001

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Electrolyte Imbalance (2196)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Event was reported by a customer from usa: over delivery.

• Brand Name: SAPPHIREPLUS INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer (Section G): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer Contact: judith antler ; yad haruzim st. 29; netanya, 42505-29 ; IS 4250529
• MDR Report Key: 8263153
• MDR Text Key: 133739574
• Report Number: 3010293992-2019-00010
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 07290109150161
• UDI-Public: 7290109150161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 15038-000-0001
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/28/2018
• Device Age: 4 YR
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention