MAUDE Adverse Event Report: HALYARD-IRVINE HOMEPUMP C-SERIES 100ML, 2ML/HR; ELASTOMERIC PUMP

Model Number C100020-10

Device Problem Infusion or Flow Problem (2964)

Patient Problem Weakness (2145)

Event Type  malfunction  

Event Description

Please reference: 2026095-2015-00097/(b)(4).Fill volume: unknown-*anp* , flow rate: 2ml/hr , procedure: unknown-*anp*, cathplace: unknown-*anp.An international distributor reported that two pump infusions ended sooner than expected.Report 2 of 2: it was reported by a physician that the pump infusion ended 24 hours in advance.The patient experienced bigger asthenia for 14 days following the incident.No medical intervention was reported.The pump is reported to be discarded and unavailable for return and analysis.Additional information was requested, however is not available at this time.

Manufacturer Narrative

(b)(4).Actual device was discarded by end user for this reported incident (b) 2026095-2015-00098.However, incident (a) 2026095-2015-00097 was reported to be returning for evaluation.This device is of the same model and lot number; therefore, halyard will provide device evaluation results upon completion of the investigation.The device history record (dhr) was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Information from this incident will be included in our product complaint and mdr trend analysis.Same lot device expected to be returned.

Manufacturer Narrative

Method: a device from the same lot number was received for an evaluation and investigation.Along with the previously reported method, a visual and microscopic inspection were conducted.Results: the visual inspection found the pump returned partially full.When opening the pinch clamp, infusion was not observed.An empty small syringe was connected at the distal luer and negative aspiration (suction) was applied a few times; no flow was obtained.The tubing was cut a few inches distal to the blue connector (base of the pump) and infusion was observed.The tubing was bonded back together.The tubing was cut a few inches distal to the filter and infusion was observed.The tubing was cut 1 inch distal to the glass orifice and infusion was observed.Infusion was not observed at the male luer adapter.The male luer adapter was examined and crystalized medication was observed.The male luer adapter was examined under a microscope and confirmed that crystalized medication was present.The male luer adapter was placed in a heated incubator for 16 hours in an attempt to dislodge any of the particulates residing inside the component.When removed from the chamber, the remaining tubing was connected to an air source for approximately 1 hour in an attempt to dislodge any remaining particulate matter.A small syringe with warm 0.9% of saline was connected at the proximal end of the male luer adapter and no flow was obtained.The sample was unable to be rehabilitated.Per the instructions for use (ifu) (14-60-591-0-04) there are several factors that may affect the flow rate including fill volume, temperature, viscosity of the drug solution, pump position, storage time and external pressure.The ifu also specifies, "delivery accuracy: when filled to labeled (nominal) volume, homepump c-series* flow rate accuracy is ±15% of the labeled (nominal) flow rate when infusion is started 0-8 hours after fill and delivering normal saline as the diluent at 31°c/88°f with the pump positioned 40 cm (16 inches) below the catheter site." conclusions: the pump was not returned for evaluation; therefore, an evaluation could not be performed and a root cause could not be determined.The device from the same lot was unable to be evaluated due to crystalized medication in the male luer adapter.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.Per the ifu, "medications or fluids must be administered per instructions provided by the drug manufacturer.Physician is responsible for prescribing drug based on each patient¿s clinical status (such as age, body weight, disease state of patient, concomitant medication, etc.)." however, the assignable cause of the reported incident is unknown.An historical review indicated that no other complaints were reported for this reported incident and related to the same lot number.As previously reported, the dhr review indicated that the lot met the process specifications, including the quality control acceptance criteria prior to release.An ifu (14-60-591-0-04) and a technical bulletin (mk-00585) factors affecting flow rate were sent to the customer.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Event Description

Please reference: 2026095-2015-00097/15-00191(a).

• Brand Name: HOMEPUMP C-SERIES 100ML, 2ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD-IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4606862
• MDR Text Key: 20364288
• Report Number: 2026095-2015-00098
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

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 Expiration Date: 03/31/2016
• Device Model Number: C100020-10
• Device Catalogue Number: 103489400
• Device Lot Number: 0201171154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 03/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1