MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,270X10,HMPMPC,-,LFR-CS,10; ELASTOMERIC LFR

Model Number C270100-10

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hyperthermia (1909)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.Method: the actual device was not returned.The device history record for the reported lot number, 02021221802, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.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

A report was received from (b)(6) stating the patient did not receive his treatment correctly.The patient remains hospitalized.The patient had an acute myeloid leukemia, aplasia induced by chemotherapy.The patient suffered hyperthermy from the pump not flowing.Antibiotic therapy was started and the patient returned to afebrile status.The patient could not tolerate all of the intravenous treatment.The patient was febrile at 39.5 ° after for 72-hours during which treatment was partially administered.No additional information was provided in regards to the patient's status.

• Brand Name: SURGPN,270X10,HMPMPC,-,LFR-CS,10
• Type of Device: ELASTOMERIC LFR
• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5759575
• MDR Text Key: 49160361
• Report Number: 2026095-2016-00080
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2016

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: Other Health Care Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: C270100-10
• Device Catalogue Number: 103488402
• Device Lot Number: 02021221802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2016
• Initial Date FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 78