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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN NEURO SCIENCES SARL MEDSTREAM CONTROL UNIT; INFUSION PUMP CONTROL UNIT
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CODMAN NEURO SCIENCES SARL MEDSTREAM CONTROL UNIT; INFUSION PUMP CONTROL UNIT Back to Search Results
Model Number 91-4205US
Device Problems Application Program Problem (2880); Unexpected Shutdown (4019)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2020
Event Type  malfunction  
Manufacturer Narrative
The control unit lot number is unavailable at this time.We have requested the unit be returned for evaluation.Once evaluated, a supplemental mdr will be filed.There was no patient consequence to this incident; this report is being filed on the basis that the malfunction could likely cause or contribute to death or serious injury if the malfunction were to recur.
 
Event Description
Medstream control unit (cu) was utilized for programming during a medstream baclofen pump refill.The pump was stopped to do the refill.When the refill procedure was completed the cu would not turn back on the be able to restart the pump.A new cu was shipped overnight to the customer to be able to program the pump to begin drug delivery.The pump was restarted on (b)(6) 2020 with no consequences to the patient.
 
Manufacturer Narrative
The device was returned on (b)(6) 2020.Lot number and serial number are added to this supplemental mdr.A device history record review and physical evaluation of the device are planned and the results will be reported in an additional supplemental mdr once complete.
 
Event Description
Medstream control unit (cu) was utilized for programming during a medstream baclofen pump refill.The pump was stopped to do the refill.When the refill procedure was completed the cu would not turn back on the be able to restart the pump.A new cu was shipped overnight to the customer to be able to program the pump to begin drug delivery.The pump was restarted on (b)(6) 2020 with no consequences to the patient.
 
Event Description
Medstream control unit (cu) was utilized for programming during a medstream baclofen pump refill.The pump was stopped to do the refill.When the refill procedure was completed the cu would not turn back on the be able to restart the pump.A new cu was shipped overnight to the customer to be able to program the pump to begin drug delivery.The pump was restarted on (b)(6) 2020 with no consequences to the patient.
 
Manufacturer Narrative
The control unit was returned and a visual investigation was performed.There were no visible damage or defects to the control unit.The control unit was connected to mains with the power cord supplied with the control unit.The control unit did not power up and the complaint was confirmed.The control unit was the connected to mains with a different power cord.The control unit powered up using the different power cord.Based on this result, it is determined that the malfunction is isolated to the power cord and not the control unit.The power cord that is supplied with the control unit is an off-the-shelf medical grade power supply.A dhr review was planned for this investigation, but given that the physical examination isolated the issue to the power cord, a dhr review is not necessary to close this investigation.This product is no longer manufactured and distributed, therefore there is no corrective action can be applied to manufacturing.This failure mode appears to be an isolated incident, as complaints are monitored and tracked per intera's post market surveillance procedure.If additional complaint(s) are reported, corrective action will be considered.
 
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Brand Name
MEDSTREAM CONTROL UNIT
Type of Device
INFUSION PUMP CONTROL UNIT
Manufacturer (Section D)
CODMAN NEURO SCIENCES SARL
rue girardet 29
lelocle, CH-24 00
SZ  CH-2400
MDR Report Key10463166
MDR Text Key219566675
Report Number3015537318-2020-00004
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P890055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number91-4205US
Device Catalogue Number914205US
Device Lot NumberCRBB2F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2020
Initial Date Manufacturer Received 07/29/2020
Initial Date FDA Received08/27/2020
Supplement Dates Manufacturer Received07/29/2020
07/29/2020
Supplement Dates FDA Received09/30/2020
02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BACLOFEN; BACLOFEN; BACLOFEN
Patient Age20 YR
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