MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULAR PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM

Model Number 16400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per field service representative (fsr), the batteries were due to be replaced on the next preventive maintenance visit so he replaced the batteries.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the operating room (or) lost power and the batteries stopped charging.The unit was plugged into alternating current (a/c).The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per the field service representative (fsr), the unit had to be powered down upon arrival to reset the battery charging circuit.The charging circuit was operating properly.The batteries were due for replacement so the fsr installed new batteries.The unit operated to the manufacturer's specifications.The suspect parts are being returned to the manufacturer for further evaluation.

Manufacturer Narrative

Updated block: device available for evaluation.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) confirmed the issue.After charging, both batteries remained out of specification for conductance.One battery measured 12.8 volts direct current (vdc) upon receipt, with a conductance measurement of 93 siemens (s), the minimum requirement for conductance on this type of battery is 200s.The second battery measured 12.5 vdc with a conductance measurement of 107s, out of specification.The batteries were installed into a lab use only (luo) heart lung machine (hlm) battery module and allowed to charge for 24 hours.Measurements after charging were 13.0 vdc / 137s and 13.0 vdc / 116s (both failing conductance).If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS 8000 MODULAR PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7365437
• MDR Text Key: 103566141
• Report Number: 1828100-2018-00150
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2018

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: 16400
• Device Catalogue Number: 16400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 05/25/2018; 06/26/2018
• Supplement Dates FDA Received: 05/09/2018; 06/18/2018; 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-06/14/12-016-C
• Patient Sequence Number: 1