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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient receiving morphine (40 mg/ml at 12. 412 mg/day) via an implanted pump. The indication for pump use was spinal pain. It was reported that on (b)(6) 2018 the pump was refilled and a large unexpected volume discrepancy was discovered. The actual residual volume (22 ml) was greater than the expected residual volume (5. 3 ml). The reporter did not know if the event logs were confirmed as normal and did not know if the pump was alarming or not. The pump off password, to permanently stop the pump, was requested by the reporter and it was provided to her. No patient symptoms were reported. No further complications were reported/anticipated.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7618214
MDR Text Key111668163
Report Number3004209178-2018-13825
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/27/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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