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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8780
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2019
Event Type  malfunction  
Manufacturer Narrative
Product analysis #(b)(4): analysis information -- 2019-09-10 13:35:00 cst pli# 10 product id# 8780 below is unedited, system generated text based on the analysis finding code(s). The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, patency testing, and pressure testing. Visual inspection identified a broken seal in the sterile package. The device history report (dhr) was reviewed and there were {no} anomalies in the manufacturing processes of the device. Analysis determined the inner tray of the sterile packaging did not properly hold the components in place. The pump was returned, and analysis found the inner tray did no properly hold the components in place and the sterile seal was compromised. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacture representative (rep) regarding a patient that was receiving unknown drug via an implanted pump. It was reported that when the provider opened the catheter packaging to use for a procedure the catheter popped out of the packaging. The event date was noted as (b)(6) 2019. When the rep looked at the packaging they noticed that the catheter was not correctly seated inside of the packaging. The rep did not use the catheter because they felt that because it had popped out of the package when they opened it that it was not sterile. They used a different catheter instead and will be returning the catheter that popped out of the packaging. It was noted the issue was resolved.
 
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Brand NameASCENDA
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9013921
MDR Text Key158110605
Report Number3004209178-2019-17537
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
Reporter Occupation
Type of Report Initial
Report Date 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2019
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/27/2021
Device Model Number8780
Device Catalogue Number8780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2019
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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