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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS ARCTICSUN GEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS ARCTICSUN GEL PADS Back to Search Results
Catalog Number 317-09
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
 
Event Description
It was reported that the patient was undergoing hyperthermia therapy and the device alerted ¿low air leak¿. The nurse reported that the flow rate was fluctuating between 0. 2 l/min - 1. 5 l/min, the inlet pressure was -5. 7 psi, and the circulation pump was 100%. Per troubleshooting, it was discovered that the device was in normothermia mode. The nurse was shown how to select the correct therapy mode. The pads were disconnected and reconnected using the proper technique. The flow rate was 0. 8 l/min, the inlet pressure was -6. 2 psi, and the circulation pump was 100%. The pads were emptied and disconnected. The device was placed in manual mode. With only the fluid delivery line attached, the flow rate was 1. 8 l/min, the inlet pressure was -6. 5 psi. The nurse connected the left thigh pad before being prompted to. The flow rate was between 0. 3 l/min and 2. 7 l/min. The inlet pressure was between -6. 7 psi and -8. 9 psi. The pad was moved to another valve set. The inlet pressure was between -4. 6 psi and -6. 1 psi. The left thigh pad was disconnected and the left chest pad was connected. The flow rate was between 0 l/min - 1. 4 l/min. The inlet pressure was between -0. 3 psi and -6. 5 psi. The nurse was advised to locate another device or switch out the pads. The nurse switched out the pads and stated that the flow rate seemed to increase. Per additional information, the charge nurse stated that the patient was able to complete therapy using the second set of pads. The first set of pads were discarded.
 
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Brand NameARTICGEL PADS
Type of DeviceARCTICSUN GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7582134
MDR Text Key110846680
Report Number1018233-2018-02131
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-09
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 Received06/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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