MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number	C270020
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is reported to be available.The device history record for the reported lot number, 0202408899, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 22-aug-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.This product incident is documented in the halyard health complaint database and identified as complaint(b)(4).
Event or Problem Description
Fill volume: 201 ml.Flow rate: unknown.Procedure: unknown.Cathplace: peripheral inserted central catheter (picc).It was reported that a pump dispensed all the medication in 72-hours, instead of 96-hours.The device failed to infuse over the expected period.The pump was dispensed and administered on (b)(6)2017, and fully infused it¿s contents over 72-hours, not 96 hours.Additional information received 03-aug-2017.No reported injury or medical intervention required from the incident.The patient's condition was reported as " unaffected".No additional information was provided.
Additional Manufacturer Narrative
One device was received empty.A baxa repeater pump was used to refill the pump with 100ml of 0.9% saline.After opening the pinch clamp no infusion was observed at the distal luer.A syringe was attached to the distal luer and negative pressure applied for a few minutes, no infusion was seen.The tubing was cut between the distal luer and glass orifice and no infusion was observed.The tubing was cut between the filter and glass orifice and infusion was observed.The pump tubing was again cut between the bladder and filter and infusion was observed.The male and female luers were used with cyclohexnone to bond the tubing back together.The pump was placed into a heated incubator at 88 degrees for 31-hours.After removing the pump from the incubator no infusion was observed.The tubing was disconnected from the bladder and connector to a pressure transducer set to 15 psi for 1 hours and no infusion was observed.The glass orifice was observed under magnification and found crystalized mediation.The investigation summary concluded that the pump did not infuse due to crystallized medication in the glass orifice.Attempts to rehabilitate the pump were not successful.The fast flow as reported by the customer was not able to be evaluated.All information reasonably known as of (b)(6) 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 07-dec-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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6819917
• Report Number: 2026095-2017-00151
• Device Sequence Number: 41343
• Product Code: MEB
• UDI-Device Identifier: 30680651135668
• UDI-Public: 30680651135668
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2017

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
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: C270020
• Device Catalogue Number: 101356602
• Device Lot Number: 0202408899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 12/11/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 12/07/2017; 12/22/2017
• Patient Sequence Number: 1
• Patient Age: 79 YR