MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP-I; DTQ

Model Number BEQ HLS7050

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problem Death (1802)

Event Date 04/26/2012

Event Type  Death  

Event Description

(b)(6) 2012: customer call from the (b)(6) hosp.I contacted a perfusionist, (b)(6), who reported that she was supporting a patient in the cath lab on chelp.(b)(6) reported that the venous lab values were not displayed on the chelp unit.Instead, dashed lines were displayed in the saturation, hgb and hct fields.She noted that when the probe was attached to the cell, values would flash on the display for a split-second but, would then quickly change to dashes.Blood values from the hosp lab indicated that the patient's blood parameters were within normal physiological levels.(b)(6) conveyed that numerous initializations of the probe did not address the issue.Also, attempts at in-vivo calibration did not resolve the situations.(b)(6) switched the venous probes and cables from another chelp, however, dashed lines continued.I collaborated with colleagues, we reviewed the info and made suggestions to the customer including: holding the probe more snugly onto the cell, checking the integrity of the pin portion of the cell, and cleaning the cell and probe with dry cloth and alcohol.No resolution (b)(6) 2012: notified via email that the patient expired over the weekend and hls disposable was not salvaged.(b)(4).

• Brand Name: CARDIOHELP-I
• Type of Device: DTQ
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4365352
• MDR Text Key: 5290487
• Report Number: 3008355164-2014-00369
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2014,04/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ HLS7050
• Other Device ID Number: 70065202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2012
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2012
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention