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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 Kinked (1339); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Interrogation of the device revealed the pump had been used to deliver 10. 0 mg/ml of remodulin at 0. 062 mg/day. Evaluation of im plantable pump serial number (b)(4) revealed pump tube binding. A kink was identified in the pump tube outlet. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider regarding a patient in a clinical study. The drug, dose and concentration being delivered by the pump, along with the indication for use, were not provided. It was indicated the pump was replaced on january 02, 2018. The pump was returned to the manufacturer for analysis. It was indicated that the device had not been used with/in or in a patient. However, it was also indicated the device had been used for treatment, and there was no patient death or patient injury. The reason for device removal was provided as ¿prophylactic removal of pump to avoid in-vivo battery depletion. ¿ it was indicated a rotor study had been performed. No further information was provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a manufacturer representative on 2018-mar-05; the patient's weight was provided.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
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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 Key7306579
MDR Text Key101288659
Report Number3004209178-2018-04260
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2011
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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