IMPELLA NOT KNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for IMPELLA NOT KNOWN manufactured by Abiomed, Inc..

Event Text Entries

[114843698] Patient's impella cp alarmed "low purge pressure". All connections both to the patient and to the pressure bag/purge fluid bag were checked to make sure there were no leaks or kinks. Staff then noticed a small puddle under the impella controller, and upon opening the cassette flap noted that there was a leak in the cassette somewhere. It appeared to be leaking to the right of the cassette from the small circular membrane. Staff quickly used the spare cassette and old purge fluid bag and switched out the cassette. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7713645
• MDR Report Key: 7713645
• Date Received: 2018-07-24
• Date of Report: 2018-06-25
• Date of Event: 2018-06-13
• Report Date: 2018-06-25
• Date Reported to FDA: 2018-06-25
• Date Reported to Mfgr: 2018-07-24
• Date Added to Maude: 2018-07-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IMPELLA
• Generic Name: TEMPORARY NON-ROLLER TYPE CARDIAC SUPPORT BLOOD PUMP
• Product Code: PBL
• Date Received: 2018-07-24
• Returned To Mfg: 2018-06-13
• Model Number: NOT KNOWN
• Lot Number: NOT KNOWN
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABIOMED, INC.
• Manufacturer Address: 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-07-24