MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH RPM 20-320 SINGLE ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00703309

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that the hl20 rpm had a safety error message.No patient was involved.(b)(4).

Manufacturer Narrative

The unit was sent to depot center for repair.According to the service report# (b)(4) dated on 2019-09-14 following was found: the technician investigated the unit.The device was repaired through cleaning the tacho film and adjusting the tacho voltage.2 years service and preventive maintenance have been performed.Full functional test and safety check as per service manual have been performed.All tests passed.Thus the failure could be confirmed.Since no parts were replaced no further investigation could be performed.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Internal reference: (b)(4).

• Brand Name: RPM 20-320 SINGLE ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8582629
• MDR Text Key: 144984514
• Report Number: 8010762-2019-00119
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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: MCP00703309
• Device Catalogue Number: 701027652
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1