FDA Adverse Event Injury Summary report: N

HLS MODULES

MDR report key: 3022618 · Received March 20, 2013

Report

Report Number: 3008355164-2013-00067
Event Type: Injury
Date Received: March 20, 2013
Date of Event: February 25, 2013
Report Date: February 26, 2013
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DTZ
PMA / PMN Number: K102627
Adverse Event: Yes
Product Problem: Yes
Report Source: Distributor report
Reporter Location: WI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4) SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND THE LOT NUMBER IS STILL UNKNOWN. THE ASSUMPTION IS THAT THE FIRST OXYGENATOR CLOTTED AND THE FLOW BEGAN TO DROP. WITHOUT RECEIVING THE SAMPLE FOR INVESTIGATION THE EXACT ROOT CAUSE CANNOT BE DETERMINED. MANUFACTURING RECORDS CANNOT BE REVIEWED WITHOUT A LOT NUMBER.

Description of Event or Problem · 1

PATIENT WAS PLACED ON VENO VENOUS SUPPORT WITH A CARDIOHELP AND HLS MODULE 7.0 ON (B)(6) 2013. THE ACT WAS AROUND 170 AT INITIATION OF THERAPY. AFTER 1-2 MINUTES ON SUPPORT, THE FLOW THROUGH THE CIRCUIT BEGAN TO DROP SIGNIFICANTLY. CLOTTING WAS SUSPECTED SO A SECOND HLS MODULE WAS PRIMED. THE PATIENT'S ACT WAS ADJUSTED TO A LEVEL ABOVE 2000 AND THE PATIENT WAS PLACED ON THE SECOND CIRCUIT WITHOUT ISSUE. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER HAS DISPOSED OF THE SAMPLE AND THE LOT NUMBER IS STILL UNKNOWN. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
114998	HLS MODULES	OXYGENATOR	DTZ	MAQUET CARDIOPULMONARY AG	HLS MODULE ADVANCED	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI		Required Intervention