MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP

Model Number 801041

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr replaced the broken slide in the tube clamp assembly.The unit operated to the manufacturer¿s specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

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

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed a broken tube clamp slide.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: LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6690776
• MDR Text Key: 79515698
• Report Number: 1828100-2017-00295
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131618
• 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: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-07/27/2006-016-C
• Patient Sequence Number: 1