MAUDE Adverse Event Report: Q CORE MEDICAL LTD. BOLUS HANDLE

Catalog Number 05022-410-0001-01

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from usa: "a hospice nurse reported to me that they have had 3 patients experience problems with administering boluses.The pump apparently will stop when the bolus button is pressed.If they don't realize right away that it's stopped, they are alerted after 5 minutes when the pump gives an alarm reading "pump has been inactive for 5 minute".If they press "continue bolus" it will resume.He also said that sometimes the patient has to put in a code to get the pump to resume.I've never heard this reported before "just wondering if you've ever encountered it?" the nurse's name is (b)(6)and he said if you need more details you are welcome to call him ((b)(6)).Delay in therapy:unknown.Need for medical intervention:unknown.Patient involvement: yes.Human harm: no.".

• Brand Name: BOLUS HANDLE
• Type of Device: BOLUS HANDLE
• 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 ; 29 yad haruzim st.; netanya, 42505-29 ; IS 4250529 ; 732388861
• MDR Report Key: 5477665
• MDR Text Key: 39751092
• Report Number: 3010293992-2016-00073
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 05022-410-0001-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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