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

Catalog Number	914201
Medical Device Problem Codes	Defective Alarm (1014); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.(b)(6).(b)(4).The product was received and is pending evaluation.The manufacturer will submit a supplemental report once the evaluation is completed.It is known that following an mri, the medstream pump may stop, cause a reset event, will stop the infusion, and elicit an audible alarm or beeping.The instructions for use (ifu) states ¿upon termination of the mri procedure, interrogate the medstream programmable infusion pump with the medstream control unit to obtain the pump¿s current status.If the infusion program has stopped, restart the program using the medstream control unit.¿ the ifu also states that failure of the pump, resulting in the cessation of drug therapy may result in the need for surgical removal of the pump.The root cause of the pump failure and lack of alarm cannot be determined without analysis of the drug infusion pump.Since the event resulted in the surgical removal of the device, it meets mdr reporting criteria as a serious injury.The device history record for device serial# (b)(4) confirmed that the device meets specifications when it was released on november 9, 2012, and when it was reworked on august 13, 2013.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported on the afternoon of (b)(6) 2018, he received information that the 40 ml medstream pump (914201 / (b)(4)) that was implanted on (b)(6) 2014, stopped working after the patient underwent a magnetic resonance imaging (mri) scan.The no hardware failure error 11 was reported.The physician was able to restart the pump without issue.The pump was last filled on (b)(6) 2018, with 40 ml morphine at a concentration of 10 mg/ml with the dose set at 3.5 mg/24 hours.The healthcare professional arranged an appointment to recheck the pump with the technical hardware key.The initial query was without issue.Subsequent test showed that the pump self-test stopped without giving an error message.The pump runs a self-test three times per day; this self-test step stopped working in the afternoon of (b)(6) 2018.After consultation with the attending physician, it was recommended that the pump be removed.The patient will receive oral medication until explantation surgery.The medstream pump was explanted on (b)(6) 2018.It was reported that the explanted medstream pump will be available to be returned for evaluation and testing.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported on the afternoon on (b)(6) 2018, he received information that the 40 ml medstream pump (914201 / nnblcd) that was implanted on (b)(6) 2014, stopped working after the patient underwent a magnetic resonance imaging (mri) scan.The no hardware failure error 11 was reported.The physician was able to restart the pump without issue.The pump was last filled on 08 october 2018, with 40 ml morphine at a concentration of 10 mg/ml with the dose set at 3.5 mg/24 hours.The healthcare professional arranged an appointment to recheck the pump with the technical hardware key.The initial query was without issue.Subsequent test showed that the pump self-test stopped without giving an error message.The pump runs a self-test three times per day; this self-test step stopped working in the afternoon of 20 november 2018.After consultation with the attending physician, it was recommended that the pump be removed.The patient will receive oral medication until explantation surgery.The medstream pump was explanted on 03 december 2018.The investigation of the returned medstream pump is documented below.It is known that following an mri, the medstream pump may stop, cause a reset event, will stop the infusion, and elicit an audible alarm or beeping.The instructions for use (ifu) states ¿upon termination of the mri procedure, interrogate the medstream programmable infusion pump with the medstream control unit to obtain the pump¿s current status.If the infusion program has stopped, restart the program using the medstream control unit.¿ the ifu also states that failure of the pump, resulting in the cessation of drug therapy may result in the need for surgical removal of the pump.The root cause of the pump failure and lack of alarm cannot be determined without analysis of the drug infusion pump.Since the event resulted in the surgical removal of the device, it meets mdr reporting criteria as a serious injury.The device history record for device serial#: (b)(4) confirmed that the device meets specifications when it was released on november 9, 2012, and when it was reworked on august 13, 2013.The device transaction log was analyzed.The transaction log of pump interrogation performed on november 19th and 20th 2018, showed no specific hardware failure error.There was an error message displayed that confirmed that the pump was stopped, and an alarm occurred, with no specific hardware failure error.The following data were extracted from the pump on february 7, 2019.1) warning window: temperature functional error, this warning is normal as pump stored in laboratory, so different temperature than to corporal body temperature.2) the programmed flow rate, valve-on time and compensation value have been verified using the following materials and are conform to the expected values.3) battery status is ok.The medstream pump underwent visual inspection and extraction of residual liquid.The pump was returned with two suture loops, two missing suture loops, with approximately 35 punctures were observed on the filling septum.There were scratches observed on the outer parts of the pump.No needle holes were observed on the bolus septum.The issue reported and documented in the complaint by the customer was confirmed based on the device transaction logs.The error message displayed confirmed that the pump was stopped due to an alarm stop, but with no specific hardware failure error as reported.The exact root cause of the issue could not be conclusively determined.The most likely cause is a possible interference with the magnetic resonance imaging (mri) examination onto the pump.However, the absence of hardware failure 11 and the software version of the pump (3.10) could not confirm this hypothesis.There is no corrective action taken based on the evaluation results of this medstream pump as it was observed to be the first occurrence.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: MEDSTREAM PUMP 40 ML
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDOS SARL; rue girardet 29; le locle jura CH-24 00; SZ CH-2400
• MDR Report Key: 8166805
• Report Number: 8031062-2018-00510
• Device Sequence Number: 11268791
• Product Code: LKK
• UDI-Device Identifier: 10886704064930
• UDI-Public: 10886704064930
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 914201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention