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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X100,HM PMP,-,EC,10; NON-DEHP PUMP - HFR
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HALYARD - IRVINE SURGPN,400X100,HM PMP,-,EC,10; NON-DEHP PUMP - HFR Back to Search Results
Model Number E401000-10
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Nausea (1970); Pain (1994); Chills (2191); Dizziness (2194)
Event Date 01/09/2017
Event Type  Injury  
Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Root cause could not be determined.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
 
Event Description
Halyard received a single report that referenced two different incidents, which were associated with separate units, involving a single patient.This is the first of two reports.Refer to 2026095-2017-00019 for the second patient.Fill volume: 400 ml, flow rate: 100 ml/hr, procedure: unknown, cathplace: unknown.It was reported that the patient experienced an acceleration of infusion twice on the same day.The first device completed infusion in 3 hours instead of 4 hours.The second device completed infusion in 2 hours instead of 4 hours.The patient exhibited symptoms of feeling sick, dizziness, nausea, chills, and pain in the arms and legs.No further information was received.
 
Manufacturer Narrative
Corrected data - describe event or problem - the initial report contained a reference to two patients.However, there was only a single patient with two events.The corrected statement has been added to describe event or problem.Type of reportable event: correct selection chosen.The pump was received empty.A baxa repeater pump was used to refill the pump with 400 ml of 0.9% saline.When opening the pinch clamp infusion was observed.Flow accuracy testing was performed on the pump.After 3 hour of testing the pump yielded a flow rate of 74.57 ml/hr which is below specification with a +/-15% tolerance.Pressure pot test was performed on the flow control tubing with the tubing detached from the pump.The tubing was connected to a pressure transducer using 8.42 psi.After 1 hour of testing the flow control tubing yielded a flow rate of 4.76 ml/hr which is below specification with a +/-15% tolerance.The filter was removed from the tubing and pressure pot testing performed a second time.After 1 hour the tubing yielded a flow rate of 93.76 ml/hr which is within specification with a +/-15% tolerance.The investigation summary concludes that fast flow was not observed.The pump infused after refilling to nominal volume.Flow accuracy testing of the pump was below specification.The first pressure pot test on the flow control tubing with the filter was below specification.After the filter was removed from the tubing of each pump pressure pot testing was performed a second time.The flow rate of the pump without the filter was within specification.It could not be determined what the filter occlusion was.Use review was conducted, it was concluded that the information provided does not suggest that the product was not used in accordance with the instructions, nor does user/facility condition seem to be contributors to the incident.Regarding patient symptoms, based on the package insert of monurol, it was concluded that the drug fosfomycin filled in the pump could possibly be a contributor to the adverse events.Root cause is deemed to be unknown.All information reasonably known as of 19-jun-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
 
Event Description
Halyard received a single report that referenced two different incidents, which were associated with separate units, involving a single patient.This is the first of two reports.Refer to 2026095-2017-00019 for the second event.
 
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Brand Name
SURGPN,400X100,HM PMP,-,EC,10
Type of Device
NON-DEHP PUMP - HFR
Manufacturer (Section D)
HALYARD - IRVINE
43 discovery
suite 100
irvine CA 92618
Manufacturer (Section G)
AVENT S. DE R.L. DE C.V.
ave noruega edificio d-1b
fraccionamiento rubio
tijuana, b.c.
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key6321183
MDR Text Key67140812
Report Number2026095-2017-00018
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/31/2017
Device Model NumberE401000-10
Device Catalogue Number103488802
Device Lot Number0202120116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/16/2017
Initial Date FDA Received02/09/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2015
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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