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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERA ONCOLOGY INTERA 3000 HEPATIC ARTERY INFUSION PUMP

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INTERA ONCOLOGY INTERA 3000 HEPATIC ARTERY INFUSION PUMP Back to Search Results
Model Number AP03000H
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A call to the clinical call line was received from a healthcare provider to report flow discrepancies in an intera 3000 hepatic artery infusion pump. The pump serial number was reported to be sn (b)(4) with an labeled intraarterial flow rate of 1. 3 ml/day. The healthcare provider reported the calculated flow rates as 1. 3 ml/day, 1. 5 ml/day, 1. 14 ml/day, 0. 96 ml/day. The dates of refills, residual volumes or infusates were not reported. No patient consequences were reported.
 
Manufacturer Narrative
Multiple contact attempts were made via email and phone to obtain more information from the healthcare provider. No additional information was provided at the time of this report. If additional information is received, a supplemental report will be filed.
 
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Brand NameINTERA 3000
Type of DeviceHEPATIC ARTERY INFUSION PUMP
Manufacturer (Section D)
INTERA ONCOLOGY
65 william street
suite 200
wellesley MA 02481
Manufacturer (Section G)
INTERA ONCOLOGY
65 william street
suite 200
wellesley MA 02481
Manufacturer Contact
sarah lapp
65 william street
suite 200
wellesley, MA 02481
7814895724
MDR Report Key15325207
MDR Text Key304298333
Report Number3015537318-2022-00016
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00850014110147
UDI-Public00850014110147
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P890055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAP03000H
Device Catalogue NumberAP-03000H
Device Lot Number28381
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2021
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: 08/30/2022 Patient Sequence Number: 1
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