MAUDE Adverse Event Report: MEDOS SARL MEDSTREAM PUMP 40 ML; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Catalog Number 914201

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Patient information: additional patient information has been requested; however, a response has not yet been received.Additional event information has been requested; however, a response has not yet been received.Additional initial reporter information has been requested; however, a response has not yet been received.The device history record (dhr) for product code 914201, lot cpcc7g (serial number (b)(4)), was electronically reviewed and was confirmed to conform to specifications when released to the stocks on march 21, 2013.Qty: (b)(4).Expiry date: august 31th, 2014.As listed in the instructions for use (ifu), pump failure is a known event associated with the use of infusion pumps and can result in a return of underlying symptoms, drug withdrawal symptoms, drug overdose or the need for surgical removal of the pump.Based on the information provided, patient symptoms related to the hardware failure is unknown.It was not reported if the pump was emptied or explanted.The ifu states that if discontinuing drug therapy for a prolonged period of time, empty the pump of the drug solution and refill it with preservative-free normal saline to maintain a patent fluid pathway.Since the event resulted in hospitalization with potential of overdose, the event meets mdr reportability as a serious injury.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported on (b)(6) 2018, the patient went in the hospital when his implanted 40 ml medstream pump (914201 / (b)(4)) that was implanted in 2015, began to ¿squeak.¿ the pump is used to administer baclofen.The patient was admitted for observation purposes.The medstream pump remains implanted.The screen error the physician read was, ¿pump hardware failure [8], empty the pump reservoir and contact customer support¿.There was no report of an actual overdose.

• Brand Name: MEDSTREAM PUMP 40 ML
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDOS SARL; rue girardet 29; le locle jura CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer Contact: gabriel alfageme ; rue girardet 29; le locle jura CH-24-00 ; SZ CH-2400 ; 9497898687
• MDR Report Key: 8210328
• MDR Text Key: 131890869
• Report Number: 8031062-2018-00511
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 10886704064930
• UDI-Public: 10886704064930
• Combination Product (y/n): N
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 914201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2013
• 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
• Patient Outcome(s): Other; Required Intervention