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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA HAND PUMP
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SYNCARDIA HAND PUMP Back to Search Results
Catalog Number 397004-001
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Manufacturer Narrative
The hand pump will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The hand pump was not supporting a patient.The customer, a syncardia certified hospital, reported that it was difficult to plug in and unplug the companion drivelines to the hand pump.
 
Manufacturer Narrative
The handpump passed all applicable testing.In an attempt to recreate the customer-reported issue, the hand pump was connected and disconnected to 10 different drivelines sets to determine any connection issues.No anomalies or difficulty was observed.The root cause of the customer-reported issue could not be determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
 
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Brand Name
SYNCARDIA HAND PUMP
Type of Device
HAND PUMP
MDR Report Key11477504
MDR Text Key245595494
Report Number3003761017-2021-00035
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397004-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Initial Date Manufacturer Received 03/03/2021
Initial Date FDA Received03/12/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received10/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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