MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVACNED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE )

Model Number 801763

Device Problems Failure to Run on Battery (1466); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2015

Event Type  malfunction  

Event Description

The field service rep (fsr) reported that during preventive maintenance (pm) of the device, he discovered the perfusion system would not boot on battery.There was no pt involvement.

Manufacturer Narrative

Per the fsr, further investigation of the data logs showed the system-1 has not been powered on since his last inspection on 08/18/2014.The batteries are both below 5.0 volts direct current (vdc) unloaded.The fsr installed new batteries, copied all data logs, and completed a full inspection.The unit operated to manufacturer specs and was returned to clinical use.The fsr talked with the perfusionist (ccp) and she was aware of the charging requirements, but forgot to tend to this backup system.The ccp will now swap systems on a regular basis or start a charging schedule on this system.The suspect batteries were returned to the mfr for further eval.The reported complaint was corroborated during the laboratory eval.The batteries were received in a severely depleted condition.After charging for 28 hours, the batteries both properly accepted charging and held up under load for the required time.The discharge test exceeded the required 50 minute load test by 15 minutes.Both batteries exceed minimum requirements for conductance and discharge tests.The data logs confirm that the system was left unplugged from power without recharging for an extended period of time.

• Brand Name: TERUMO ADVACNED PERFUSION SYSTEM 1
• Type of Device: APS 1 (HEART LUNG CONSOLE )
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4620428
• MDR Text Key: 5653418
• Report Number: 1828100-2015-00205
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• 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: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1