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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.
 
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Brand NameMEDSTREAM CONTROL UNIT
Type of DeviceINFUSION PUMP CONTROL UNIT
Manufacturer (Section D)
CODMAN NEURO SCIENCES SARL
rue girardet 29
lelocle, CH-24 00
SZ CH-2400
Manufacturer (Section G)
INTERA ONCOLOGY
65 william street
suite 200
wellesley MA 02481
Manufacturer Contact
sarah lapp
65 william street
suite 200
wellesley, MA 02481
7814895724
MDR Report Key10463166
MDR Text Key219566675
Report Number3015537318-2020-00004
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician Assistant
Type of Report Initial,Followup,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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