• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/02/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_prog, serial#: unknown, product type: programmer, physician. Product id: neu_unknown_prog, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient receiving an unknown intrathecal medication via an implanted pump. It was reported the pump was showing low reservoir and end of service (eos) alarm which turned out to actually, be the elective replacement indicator (eri) alarm. The hcp wanted code to shut down the pump. It was reviewed code was not required if pump was at eos. The status was checked on the home screen, which showed eri had occurred and a replace pump by date of (b)(6) 2019. It was confirmed this date on programmer was correct. The pump was going to be replaced and they wanted to shut it down until then. It was confirmed she also wanted infusion to be shut down versus just the alarms. Provided code of 3525, caller stated she tried to enter it but it said it was the incorrect code. It was confirmed the pump date and time was correct from home screen. It was noted the hcp would just program the pump to minimum rate instead. Reviewed how to silence alarms on home screen as well as enter a volume in for reservoir and low reservoir volumes to allow her to update. The hcp was able to update the pump successfully. Patient symptoms were not reported. Additional information was received from a company representative (rep) on (b)(6) 2021 indicated this patient's replacement was urgently put on his schedule and he was wanting to know how to get the catheter information off of a pump that has potentially reached end of service (eos) or had been shut down. It was further reported the rep thought the patient might be in the hospital with withdrawal, but he would have to confirm that later. Additional information was received again from hcp via the rep on (b)(6) 2021 and it was indicated the pump was replaced on (b)(6) 2021 and the event was resolved. The patient¿s weight was not recorded, and the pump would not be returned as it was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11365863
MDR Text Key233255275
Report Number3004209178-2021-03062
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
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2015
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received02/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/23/2021 Patient Sequence Number: 1
-
-