MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON RESPONSE INSTRUMENT; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Model Number HRS.110

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron response instrument, serial number (b)(4).This mdr captures the child case (complaint (b)(4)) for the lot number of the hemochron flip top p214 act tubes used during the procedure.Method codes: device not returned.Process evaluation performed.Dhf review shows instrument repair in (b)(6) 2014 with replacement of test wells, battery, cpu and printer.No ncs.Results code: no findings available.Conclusion code: conclusion not yet available.Accriva diagnostics has requested all data required for form 3500a.Fields for which data were not obtainable or are not applicable are intentionally left blank.This is the initial 30-day report that precedes the instrument evaluation.Mdr follow-up #1 will be submitted if the device is returned to the manufacturer for evaluation.

Event Description

A healthcare professional reported discrepant act results with a different hemochron response (serial number (b)(4)) and low-range act tube-based coagulometer during a vascular surgical procedure on a (b)(6) infant with unspecified identity, age and gender.The target act for this procedure was >200 seconds.Following an intravenous 40 unit/kg heparin dose, the act result was reported as 145 seconds, which was a lower than expected result.A repeat blood sample was drawn 5 minutes later and was reported as 45 seconds, which was also a lower than expected result.An additional 15 units/kg of intravenous heparin was given and the act was measured on the hemochron response instrument named in this complaint (serial number (b)(4)) 25 minutes later.The act result was reported as 143 seconds, which was also a lower than expected result.The procedure was completed successfully.Both electronic and liquid quality controls passed prior to the procedure.

Manufacturer Narrative

Corrected data: model # hrs.110, catalog # hrs.110.

Event Description

Follow-up #2.

Manufacturer Narrative

Mdr 2250033-2018-00020 follow-up #1 provides the results of the instrument evaluation for the hemochron response instrument, serial number (b)(4) named in accriva diagnostics' complaint number (b)(4).Method code: 10: testing of actual/suspected device.Results code: 213: no device problem found.Donor whole blood was assayed and results were found to be within specification.Electronic qc passed as well.Conclusion code: 67: no problem detected.This follow-up mdr documents closure of this complaint.No additional reports are required.

Event Description

Follow-up #1.

• Brand Name: HEMOCHRON RESPONSE INSTRUMENT
• Type of Device: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7871419
• MDR Text Key: 120106406
• Report Number: 2250033-2018-00020
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• PMA/PMN Number: K030818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2018

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 Model Number: HRS.110
• Device Catalogue Number: HRS.110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 08/22/2018
• Supplement Dates FDA Received: 09/14/2018; 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMOCHRON P214 ACT TUBE, LOT B8PGE005
• Patient Weight: 10