MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HEMOCONCENTRATOR BC 60 PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number NEW BC 60 PLUS SET

Device Problem Increase in Pressure (1491)

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

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

"the customer started to use the devise without rinsing.Right after, the pressure of the hemoconcentrator increased.(more than 400mmhg).Checked around the pump, and then restarted the device, but the pressure didn't drop and remained high.The customer changed the circuit, then the devise was no problem to use.After that, the extracorporeal circulation was finished without any trouble.- act approx.400 seconds.- hct 24%.- no drug/medicine applied.No adverse effects on the patient.The user has always been using the devise without rinsing, but the pressure increased only this time.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary forwarded the product to (b)(4) for laboratory investigation as it has been manufactured by (b)(4).A device history record was performed by gambro.Thereby no issues were found for this lot number and no further complaints were reported for this lot number.Furthermore the product was investigated by the technical support of (b)(4).A performance test according (b)(4) product master was done and all tested parameters are well within the range.The returned product showed no deviation from specified (b)(4) values.Stated from (b)(4) a specific root cause for this reported failure could not be identified.There is no information available reasonably indicating a general lot issue.Based on the reported event and the investigation of maquet the included product was used beyond the usage described in our labeling and cleared intended use.The instructions for use (ifu)art.# 70105.2164, common device name: ifu: bc 20/60/140 plus g-153, chapter 4: information and precautions, clearly state the following: "prime and de-air the hemoconcentrator before use." based on the available information and the investigation results obtained the reported failure could not be confirmed.The cause of this failure was determined to not be attributed to a device related malfunction.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

(b)(4).

• Brand Name: HEMOCONCENTRATOR BC 60 PLUS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5169147
• MDR Text Key: 28986666
• Report Number: 8010762-2015-01120
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

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: NEW BC 60 PLUS SET
• Device Catalogue Number: 70105.4662
• Device Lot Number: 92149317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 10/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention