MAUDE Adverse Event Report: MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Catalog Number 91-4200

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information, it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time, this complaint is considered closed.Device not available.

Event Description

There was a situation with one of the codman pump patients whom we could not refill before the refill alarm date.On telemetry, it was shown pump empty alarm was on even though it was showing 2.9ml of solution still in the reservoir.Was that alarm an audible alarm or just an alarm message? i did not hear any audible alarm.Patient as well as the carer did not report any audible alarm sound.There was no report of injury to the patient.

Manufacturer Narrative

Corrected udi: (b)(4).Upon completion of the investigation it was noted that the on (b)(6) 2017, codman was contacted by the clinician regarding a pump empty alarm.He wanted to understand why a pump empty alarm was reported by the control unit after a pump interrogation whereas the pump reservoir was filled with 2.9ml and why he did not hear the associated audible alarm.The field support senior engineer provided a reminder about the alarms, as per medstream programming guide: the pump¿s alarm sounds an alert for a variety of conditions.The alarm is a short, single-tone beep that repeats every 30 seconds.You must use the control unit to interrogate the pump to find out why the alarm is sounding.Information about the pump problem displays on the control unit screen.Note that the alarm continues until you correct the problem.All pump alarms can be disabled for 24 hours.The pump battery low alarm can be disabled permanently.After interrogating the pump, the control unit beeps in response to some of the pump alarms.For moderate alarms, the control unit emits three beeps, repeated every 30 seconds.For critical alarms, the control unit emits 10 beeps, repeated every 15 seconds.It was explained to the clinician that a pump empty alarm is activated (=audible alarm + message on the cu when interrogating the pump) when the volume of drug measured in the reservoir is below 3ml.There are two possible explanations of the reported event: first, the drug volume is measured by the fill level sensor at the pump self-tests (during the night).It is possible that the drug volume was still above 3ml at the last self-test (=no alarm) and became below this limit before the pump was interrogated.This would explain why the pump audible alarm was not activated.Second, the pump audible alarm was activated but it couldn¿t be perceived by the patient or physician, even by putting his ear within 12 inched from the patient¿s skin surface.This might be due to some back noises.It was recommended to try hearing the alarm with a stethoscope in such situations.Whatever root cause it is, the pump was working properly according to the provided information, the medstream pump has reacted as expected in such situation.Therefore, the reported event is not considered as a product¿s defect.The device history record of product code 91-4200, lot cnlbzk; serial number (b)(4) was reviewed and confirmed that the product was conformed to the specifications when released on september 25th, 2012.The reported event is not evaluated as a product¿s defect, since it¿s part of the normal functioning of the pump.According to the medstream programming guide, the root cause of this event could be that the drug volume was still above 3ml at the last self-test (=no alarm) and became below this limit before the pump was interrogated, this however could not be determined.The pump is still implanted and is working properly.Should additional information be provided, or should the product be returned, this complaint will be reopened and the product or information will be evaluated.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6671148
• MDR Text Key: 78595730
• Report Number: 1226348-2017-10452
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 91-4200
• Device Lot Number: CNLBZK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• 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