MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HEART-LUNG MACHINE HL20

Model Number 70102.8580

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

A field safety technician opened the rpm and one belt is broken (the second one seems to be ok).He measured the belt tension 445 hz.Possible root cause: defective belt from a factory, tension too high, maybe combination of both.He repaired (belt replacement) / ordering new motor isolation kit for better adjustment of tension.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.

Event Description

It was reported that during the surgery, the rpm module reported an error "belt slip".The perfusionist stopped the pump but the error was still there.So they stopped the "suction" function.(b)(4).

• Brand Name: HEART-LUNG MACHINE HL20
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4972743
• MDR Text Key: 22439194
• Report Number: 8010762-2015-00866
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,study,user faci
• Reporter Occupation: Not Applicable
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.8580
• Device Catalogue Number: 70102.8580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other