MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE¿SARNS 8000 UNIVERSAL ROLLER

Model Number 16402

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr removed the broken tongue and installed a new one.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the tongue on the roller pump was broken.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The product surveillance technician (pst) visually verified that the tongue was broken.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 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE¿SARNS 8000 UNIVERSAL ROLLER
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7342041
• MDR Text Key: 102597942
• Report Number: 1828100-2018-00134
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

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: Other
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2005
• 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