MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH ROTA FLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number BO-RF-32#ROTAFLOW

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

The product in question was not requested for return because maquet cardiopulmonary is aware of a similar complaint # (b)(4) which was investigated with the following results: the visual inspection shows that the centrifugal pump has been delivered in the sterile package, which was not damaged neither outside nor inside.The blood inlet connector shows scratches.The cover cap was not damaged.The blood outlet connector also shows crack.The conus of the cover cap shows slight chips and bruise.Thus the failure could be confirmed.The most probable root cause could be determined as hard protection cap caused the crack in the connector.Due to inner forces, the connectors can exhibit damage if the cap is mounted too tightly or if the diameter of the inner cone of the blue cap fails within the upper tolerance of the specification.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that during pcps setup, a tube was connected to the rotaflow inlet, and then the cap on the outlet side was removed a crack was noticed on the outlet connector on the rf-32.The affected rf-32 was never used on patient.Replaced during setup.There is no patient health damage.Complaint number: (b)(4).

• Brand Name: ROTA FLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 8631104
• MDR Text Key: 145939609
• Report Number: 8010762-2019-00130
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2021
• Device Model Number: BO-RF-32#ROTAFLOW
• Device Catalogue Number: 701032035
• Device Lot Number: 70126770
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1